Non-Squamous Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
Verified date | December 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/=18 years of age - Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer - At least 1 measurable disease lesion as per RECIST criteria - Confirmed presence of EGFR in tumor tissue - ECOG performance status 0-1 - Adequate hematological, renal and liver function Exclusion Criteria: - Prior chemotherapy or treatment with another systemic anti-cancer agent - Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief - Symptomatic or active CNS metastases - Recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg) - Requirement for steroids > 40 mg prednisolone |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Belgium, France, Germany, Italy, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 2: Progression-free survival, according to RECIST criteria by CT/MRI | 23 months | No | |
Primary | Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) | 6 months | No | |
Secondary | Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed | multiple sampling cycles 1-6 (18 weeks) | No | |
Secondary | Duration of response, according to RECIST criteria by CT/MRI | from response to disease progression | No | |
Secondary | Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI | 23 months | No | |
Secondary | Overall survival | 23 months | No | |
Secondary | Overall response rate (ORR), according to RECIST criteria by CT/MRI | 23 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02264990 -
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
|
Phase 3 | |
Completed |
NCT01328951 -
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
|
Phase 3 | |
Completed |
NCT01664533 -
An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
|
N/A | |
Completed |
NCT00976456 -
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT00988936 -
Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
|
Phase 2 | |
Completed |
NCT02596958 -
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
|
N/A | |
Completed |
NCT00974584 -
A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT00451906 -
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
|
Phase 4 | |
Completed |
NCT03329911 -
A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT03671538 -
Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin
|
N/A | |
Completed |
NCT01512420 -
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
|
N/A | |
Completed |
NCT01204697 -
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
|
Phase 2 | |
Terminated |
NCT00760929 -
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
|
Phase 2 | |
Withdrawn |
NCT03319316 -
Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)
|
Phase 2 | |
Recruiting |
NCT06334757 -
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure
|
Phase 2 | |
Recruiting |
NCT06396065 -
Phase III Study of AK112 for NSCLC Patients
|
Phase 3 | |
Completed |
NCT01174563 -
A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
|
Phase 2 | |
Terminated |
NCT01990261 -
A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment.
|
N/A | |
Completed |
NCT01763671 -
Paclitaxel-bevacizumab in Advanced Lung Cancer
|
Phase 3 | |
Completed |
NCT01836133 -
An Observational Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
|
N/A |