Metastatic NSCLC Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination With Carboplatin and Pemetrexed in Adults With Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on Immunotherapy
NCT number | NCT05403385 |
Other study ID # | A2A-005 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 26, 2022 |
Est. completion date | May 2025 |
Part 1 of the study determines the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving specific first line treatments for Stage 3 or metastatic non-small cell lung cancer. Part 2 compares the efficacy of inupadenant to placebo when both are combined with carboplatin and pemetrexed for patients that progressed after receiving the same first line treatments for Stage 3 or metastatic non-small cell lung cancer.
Status | Recruiting |
Enrollment | 192 |
Est. completion date | May 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable (Stage III) NSCLC of nonsquamous pathology that has relapsed or progressed 2. Measurable disease as defined by RECIST v1.1 criteria 3. PD-L1 expression status available at or after the time of diagnosis of advanced or metastatic NSCLC disease 4. Can provide existing biopsy taken within 2 years prior to entering trial or provide fresh biopsy 5. Have relapsed or progressed after prior anti- PD-(L)1 therapy as follows: 1. At least 12 weeks of treatment with only 1 line of anti-PD-(L)1 therapy (mono or combo) in the metastatic setting, without concomitant chemotherapy OR 2. At least 12 weeks of single-agent durvalumab 6. Adequate organ function 7. ECOG performance status of 0 to 1. Exclusion Criteria: 1. Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. 2. Presence of active second malignancy 3. EGFR or ALK mutation. Participants with presence of other driver mutations are allowed if targeted therapy is not available as per local standard of care. 4. Preexisting gastrointestinal disorders/conditions that may interfere with ingestion or absorption of oral medications. 5. History of or active (non-infectious) pneumonitis/ interstitial disease or lung fibrosis, except for Grade 1 pneumonitis from prior chemoradiation therapy (Stage III patients). 6. History of or active autoimmune disease requiring systemic treatment in the last 6 months or persistent immune-mediated toxicity caused by checkpoint inhibitor therapy > Grade 2 7. Known active or chronic hepatitis B or C infection unless adequately treated for at least 4 weeks with no detectable viral load; known infection with human immunodeficiency virus (HIV) unless receiving antiretroviral therapy with well-controlled disease. 8. History of life-threatening toxicity related to prior immune therapy or any toxicity resulting in permanent discontinuation from prior therapy. 9. Diagnosis of immunodeficiency or any condition requiring concurrent use of systemic immunosuppressants or corticosteroids. 10. Active infection requiring systemic therapy = 7 days prior to first dose of study treatment. 11. Any other oncologic treatments administered =14 days (<28 days in case of checkpoint inhibitor therapy) prior to first dose of study treatment. Also, ongoing adverse effects from such treatment > Grade 1 with the exception for alopecia and Grade 2 peripheral neuropathy. 12. Non-study related minor surgical procedure =7 days, or major surgical procedure of = 5 weeks prior to first dose of study treatment. 13. Uncontrolled or significant cardiovascular disease 14. History of allergy or hypersensitivity to any of the study treatments. 15. Treatment with a live or live attenuated vaccine. 16. Treatment with moderate or strong inducers or inhibitor of CYP 3A4, inhibitors of P-glycoprotein, or substrates of breast cancer resistance protein 17. Pregnant or breast-feeding 18. Male and Female participants: Lack of agreement to use highly effective method of contraception during treatment and for 6 months after the last administration of chemotherapy |
Country | Name | City | State |
---|---|---|---|
Belgium | Algemeen Ziekenhuis Sint-Lucas | Gent | |
Belgium | Jessa Ziekenhuis | Hasselt | |
Belgium | Algemeen Ziekenhuis Sint-Maarten | Mechelen | |
Belgium | C.H.U. Ambroise Pare | Mons | |
Belgium | CHU UCL Namur | Namur | |
Belgium | AZ Delta | Roeselare | |
Canada | William Osler Health System | Brampton | Ontario |
Czechia | Fakultni nemocnice Olomouc | Olomouc | |
Czechia | Vseobecna Fakultni Nemocnice | Praha | |
Czechia | Vseobecna Fakultni Nemocnice | Praha | |
France | Hopital Saint Andre - CHU de Bordeaux | Bordeaux | |
France | Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | |
France | CHU de Caen | Caen | |
France | Centre Georges Francois Leclerc | Dijon | |
France | Hopital Nord de Marseille | Marseille | |
France | HIA Begin | Saint-Mandé | |
Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
Italy | Ospedale San Luca | Lucca | |
Italy | Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico | Milan | |
Italy | Istituto Nazionale dei Tumori | Milano | |
Italy | Oncologia Casa Di Cura Polispecialistica Dott Pederzoli | Peschiera del Garda | |
Italy | Gruppo Humanitas - Istituto Clinico Humanitas | Rozzano | |
Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o | Krakow | |
Poland | Uniwersytet Medyczny w Lodzi Klinika Pulmonologii Ogolnej i Onkologicznej | Lódz | |
Poland | Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie | Olsztyn | Warminsko-Mazurskie |
Poland | Nzoz Formed 2 | Oswiecim | |
Poland | NZOZ Ars Medical Sp. z o.o. | Pila | |
Poland | NZOZ Medpolonia Sp. Z o.o. | Poznan | |
Poland | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie | Warszawa | Mazowieckie |
Spain | Centro Oncologico de Galicia | A Coruña | |
Spain | Hospital General Universitario de Alicante | Alicante | |
Spain | Hospital Infanta Cristina | Badajoz | |
Spain | Hospital Quiron Barcelona - Instituto Oncologico Baselga | Barcelona | |
Spain | Consorcio Hospitalario Provincial de Castellon | Castellón De La Plana | |
Spain | Hospital Universitario Lucus Augusti | Lugo | |
Spain | Hospital Universitario Fundacion Jimenez Diaz | Madrid | |
Spain | Althaia Hospital | Manresa | |
Spain | Complejo Hospitalario Universitario de Ourense | Ourense | |
Spain | Hospital Universitario Son Espases | Palma De Mallorca | Illes Balears |
Spain | Complejo Hospitalario de Navarra (CHN) | Pamplona | |
Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | HFR Fribourg | Villars-sur-Glâne | |
Switzerland | Stadt Zuerich Stadtspital Triemli | Zürich | |
United States | Gabrail Cancer & Research Center | Canton | Ohio |
United States | Carolina Institute for Clinical Research | Fayetteville | North Carolina |
United States | Highlands Oncology Group | Fayetteville | Arkansas |
United States | Summit Medical Group PA | Florham Park | New Jersey |
United States | Gettysburg Cancer Center | Gettysburg | Pennsylvania |
United States | Nebraska Cancer Specialists | Omaha | Nebraska |
United States | Mid-Florida Hematology & Oncology Centers, PA | Orange City | Florida |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | UT Health East Texas HOPE Cancer Center | Tyler | Texas |
United States | Innovative Clinical Research Institute (ICRI) | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
iTeos Belgium SA |
United States, Belgium, Canada, Czechia, France, Italy, Poland, Spain, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-finding to determine recommended Phase 2 dose | Incidence of dose-limiting toxicities | At the end of Cycle 1 (each cycle is 21 days) | |
Primary | Incidence of treatment-emergent adverse events [Safety and Tolerability] | Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities. | Duration of intervention (up to 24 months) plus 30 days follow-up | |
Primary | Progression-free survival [Efficacy] | Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, which ever comes first | From randomization to first-documented radiological progression or date of death from any cause, whichever comes first, assessed up to 24 months. | |
Secondary | Overall Response Rate [Efficacy] | Proportion of participants with a best overall response of complete (CR) or partial (PR) response as assessed by RECIST v1.1 | From randomization to first-documented radiological improvement, if applicable, assessed up to 24 months. | |
Secondary | Duration of Response [Efficacy] | Time from first CR or PR to first documented progression or death from any cause, per RECIST v1.1 | From first-documented CR or PR to first radiological progression or date of death, whichever comes first, assessed up to 24 months. | |
Secondary | Percent Change in Tumor Size [Efficacy] | Change in sum of size of target tumors from baseline, per RECIST v1.1 | From randomization to the documented radiological assessment with the smallest tumor size sum, assessed up to 24 months. | |
Secondary | Disease Control Rate [Efficacy] | Proportion of participants with CR, PR, or stable disease (SD) sustained over at least 2 consecutive tumor assessments, per RECIST v1.1 | From randomization to second-documented radiological CR, PR or SD, if applicable, assessed up to 24 months. | |
Secondary | Overall Survival [Efficacy] | Time from randomization to date of death due to any cause. | From randomization to death due to any cause, assessed up to 24 months. | |
Secondary | Efficacy (Patient Reported Outcomes) | Time to definitive deterioration in global health status/quality of life | Duration of intervention (up to 24 months) plus 30 days follow-up | |
Secondary | Peak plasma concentration (Cmax) | Cmax for inupadenant and its primary metabolite as observed by assessment of concentration-time profile | From first dose of inupadenant through 24 hours | |
Secondary | Time to peak plasma concentration (Tmax) | Tmax for inupadenant and its primary metabolite as observed by assessment of concentration-time profile | From first dose of inupadenant through 24 hours | |
Secondary | Plasma half-life (T-1/2) | T-1/2 for inupadenant and its primary metabolite | At the end of Cycle 12 (each cycle is 3 weeks) | |
Secondary | Area under the concentration-time curve (AUCinf) | AUC from Time 0 extrapolated to infinity for inupadenant and its primary metabolite | At the end of Cycle 12 (each cycle is 3 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05091190 -
Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers
|
N/A | |
Recruiting |
NCT04170634 -
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
|
||
Recruiting |
NCT05339568 -
Patient's Whole Process Follow-up Management(HOPE-1)
|
||
Recruiting |
NCT05255302 -
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04615884 -
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
|
N/A | |
Recruiting |
NCT04846452 -
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
|
Phase 2 | |
Recruiting |
NCT05480865 -
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
|
Phase 1 | |
Terminated |
NCT03417882 -
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
|
Phase 2 | |
Recruiting |
NCT03589339 -
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
|
Phase 1 | |
Suspended |
NCT05617313 -
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT06159790 -
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
Phase 3 |