A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657434
• Other study ID #: GO29438
• Secondary ID: 2015-003605-42
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2016
• Est. completion date: December 13, 2022

Study information

• Verified date: November 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: December 13, 2022
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous
• No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and ALK status require test results at screening from a local or central laboratory
• Participants who have received prior neo-adjuvant, radiotherapy, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy
• Participants should submit a pre-treatment tumor tissue sample if available before or within 4 weeks after enrollment. If tumor tissue is not available, participants are still eligible
• For participants enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function
• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of cisplatin
• For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm Exclusion Criteria: Cancer-Specific Exclusions
• Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than or equal to (>= 2) weeks prior to randomization
• Leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper limit of normal)
• Malignancies other than NSCLC within 5 years prior to randomization
• Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not eligible are excluded)

General Medical Exclusions:

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• History of certain autoimmune disease
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
• All participants will be tested for human immunodeficiency virus (HIV) prior to the inclusion into the study and HIV-positive participants will be excluded from the clinical study
• Severe infections within 4 weeks prior to randomization
• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
• Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures

Exclusion Criteria Related to Medications and Chemotherapy:

• Prior treatment with EGFR inhibitors or ALK inhibitors
• Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to initiation of study treatment
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
• Treatment with systemic immunosuppressive medications

Exclusion Criteria Related to Chemotherapy:

• History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
• Participants with hearing impairment (cisplatin)
• Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)
• Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45 mL/min for carboplatin

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Atezolizumab
Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
• Carboplatin
Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.
• Cisplatin
Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.
• Pemetrexed
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.

Locations

Country	Name	City	State
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Buenos Aires
Argentina	Fundacion Clinica Colombo	Cordoba
Argentina	Clinica Viedma S.A.	Viedma
Australia	Ballarat Health Services	Ballarat	Victoria
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	St George Hospital; Medical Oncology	Sydney	New South Wales
Australia	Sydney Adventist Hospital; Clinical Trial Unit	Sydney	New South Wales
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Belgium	AZ Maria Middelares	Gent
Belgium	Clinique André Renard; Pneumologie	Herstal
Belgium	AZ Delta (Campus Rumbeke), Apotheek	Roeselare
Bulgaria	Multiprofile Hospital for Active Treatment Serdika EOOD	Sofia
Chile	Health & Care SPA	Santiago
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Chile	Hospital Clinico Vina del Mar?	Viña del Mar
China	Beijing Cancer Hospital	Beijing
China	Beijing Friendship Hospital Affiliated of Capital University of Medical Science	Beijing Shi
China	Hunan Cancer Hospital	Changsha CITY
China	Changzhou First People's Hospital	Changzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou City
China	Anhui Provincial Hospital; 2F,Tumor chemotherapy Department	Hefei
China	Anhui Provincial Hospital; Respiratory Department	Hefei
China	Qilu Hospital	Jinan City
China	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City
China	Shanghai Chest Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	First Hospital of China Medical University	Shenyang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Zhejiang Cancer Hospital	Zhejiang
France	Institut Sainte Catherine	Avignon
France	Hopital Louis Pradel; Pneumologie	Bron
France	Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne	Clermont-ferrand
France	Centre Hospitalier Intercommunal; Service de Pneumologie	Creteil
France	Polyclinique de Limoges - Site Chenieux; Oncologie Medicale	Limoges
France	Hopital Nord AP-HM	Marseille
France	Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie	Montpellier
France	Centre Hospitalier de Mulhouse - Hopital Emile Muller	Mulhouse
France	Hopital d'Instruction des Armees de Begin	Saint-Mande
France	Hopital d Instruction des Armees de Sainte Anne	Toulon
Hungary	Veszprem Megyei Tudogyogyintezet	Farkasgyepu
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Hungary	Markusovszky Hospital	Szombathely
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Ireland	Mater Misecordiae University Hospital	Dublin
Ireland	St James's Hospital	Dublin
Israel	Barzilai Medical Center	Ashkelon
Israel	Edith Wolfson Medical Center	Holon
Israel	Rabin Medical Center	Petach Tiqwa
Italy	Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica	Lecce	Puglia
Italy	Ospedale San Luca - USL2 Lucca	Lucca	Toscana
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica	Orbassano (TO)	Piemonte
Italy	Azienda Ospedaliero Universitaria di Parma	Parma	Emilia-Romagna
Italy	Ospedale Santa Maria Delle Croci	Ravenna	Emilia-Romagna
Italy	Azienda Policlinico Umberto I	Roma	Lazio
Italy	Istituto Nazionale Tumori Regina Elena	Roma	Lazio
Italy	Ospedale Casa Sollievo Della Sofferenza IRCCS	San Giovanni Rotondo	Puglia
Italy	Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica	Taormina	Sicilia
Japan	National Hospital Organization Nagoya Medical Center	Aichi
Japan	National Cancer Center Hospital East	Chiba
Japan	Hiroshima University Hospital	Hiroshima
Japan	National Hospital Organization Asahikawa Medical Center	Hokkaido
Japan	National Hospital Organization Himeji Medical Center	Hyogo
Japan	Kanazawa University Hospital	Ishikawa
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Tohoku University Hospital	Miyagi
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Osaka Medical and Pharmaceutical University Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Saga University Hospital	Saga
Japan	Tokushima University Hospital	Tokushima
Japan	Juntendo University Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	NTT Medical Center Tokyo	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Tokyo
Japan	National Hospital Organization Yamaguchi - Ube Medical Center	Yamaguchi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Latvia	Riga East Clinical University Hospital Latvian Oncology Centre	Riga
Lithuania	Panevezys Hospital	Panevezys
Malaysia	Advanced Medical and Dental Institute; Kompleks Klinikal	Kepala Batas	Penang
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	FED. Territory OF Kuala Lumpur
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Ziekenhuis Gelderse Vallei	EDE
Netherlands	Ziekenhuis St. Jansdal	Harderwijk
Netherlands	Zuyderland Medisch Centrum - Sittard Geleen	Sittard-Geleen
Netherlands	ETZ TweeSteden	Tilburg
Peru	Hospital Nacional Cayetano Heredia	Lima
Portugal	Hospital Beatriz Angelo	Loures
Portugal	Unidade Local de Saude de Matosinhos SA	Matosinhos
Portugal	Hospital CUF Porto; Servico de Imunoalergologia	Senhora Da Hora - Porto
Romania	Medisprof SRL	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta	Constanta
Romania	Euroclinic Center of Oncology SRL	Iasi
Russian Federation	Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk	Moskovskaja Oblast
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl
Spain	Centro Oncologico de Galicia COG; Medical Oncology	A Coruna	LA Coruña
Spain	Hospital General Univ. de Alicante	Alicante
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica	Barcelona
Spain	C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia	Burgos
Spain	Onkologikoa; Ensayos Clinicos	Donostia	Guipuzcoa
Spain	Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia	El Palmar	Murcia
Spain	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante
Spain	Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica	Girona
Spain	ICO L'Hospitalet; Servicio de oncologia medica	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Lucus Augusti; Servicio de Oncologia	Lugo
Spain	HM Sanchinarro ? CIOCC	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia	Malaga
Spain	Hospital de Mataro	Mataro	Cantabria
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Complejo Hospitalario Nuestra Senora de Valme	Seville	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Taiwan	Buddhist Dalin Tzuchi General Hospital	Dalin, Chiayi
Taiwan	E-DA Hospital; Chest	Kaohsiung
Taiwan	Chi Mei Medical Center Liou Ying Campus	Liuying Township
Taiwan	National Taiwan Uni Hospital; Internal Medicine	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Ukraine	MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology	Cherkasy
Ukraine	MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council	Dnipropetrovsk	Katerynoslav Governorate
Ukraine	Private Enterprise Private Manufacturing Company Acinus	Kirovograd
Ukraine	Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept	Kyiv	Kharkiv Governorate
Ukraine	Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department	Sumy
Ukraine	MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology	Zaporizhzhya
United Kingdom	Bristol Haematology and Oncology centre	Bristol
United Kingdom	Velindre Hospital	Cardiff
United Kingdom	Gartnavel General Hospital; Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Charing Cross Hospital	London
United Kingdom	St George?s Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Derriford Hospital; Plymouth Oncology Centre	Plymouth
United Kingdom	Queen's Hospital	Romford
United Kingdom	Royal Cornwall Hospital	Truro
United States	University of Michigan	Ann Arbor	Michigan
United States	Northside Hospital	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	Swedish Cancer Institute	Cary	North Carolina
United States	Virginia Cancer Specialists (Fairfax) - USOR	Fairfax	Virginia
United States	Fort Wayne Med Oncology & Hematology Inc	Fort Wayne	Indiana
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Goshen Health System	Goshen	Indiana
United States	CHI Health St. Francis	Grand Island	Nebraska
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Oncology Consultants PA	Houston	Texas
United States	University of Kentucky; Markey Cancer Center	Lexington	Kentucky
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Orlando Health Inc.	Orlando	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Allegheny Cancer Center	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	University of Washington	Seattle	Washington
United States	St. Joseph Heritage Healthcare	Sebastopol	California
United States	Stamford Hospital; BCC, MOHR	Stamford	Connecticut
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	HealthCare Research Network II, LLC - PPDS	Tinley Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Chile,  China,  France,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Netherlands,  Peru,  Portugal,  Romania,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.	Randomization up to approximately 39 months
Primary	Overall Survival (OS)	OS is defined as time from randomization to death from any cause.	Randomization up to approximately 39 months
Secondary	Overall Survival Rate at Year 1	The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.	Year 1
Secondary	Overall Survival Rate Year 2	The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.	Year 2
Secondary	Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1	An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.	Randomization up to approximately 25 months
Secondary	Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1	DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.	Randomization up to approximately 25 months
Secondary	Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score	EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A =10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Secondary	Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score	The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A=10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Secondary	Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score	Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of =0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of=0.5 points for chest pain score is considered to be clinically significant.	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Secondary	Minimum Observed Serum Atezolizumab Concentration (Cmin)	Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)	Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months)
Secondary	Maximum Observed Serum Atezolizumab Concentration (Cmax)	Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)	Day 1 of Cycle 1 (Cycle length=21 days)
Secondary	Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary	Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary	Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab	Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)	Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months)