A Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/-Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies
GFPC 06-2018
A Multicentre Phase II, Open-label, Non-randomized Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/- Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies
1 other identifier
interventional
150
1 country
31
Brief Summary
The objective of this study is to assess the efficacy of the combination of Platinum (carboplatin or cisplatin), Pemetrexed, Atezolizumab+/- Bevacizumab if eligible, in stage IIIB/IV non-squamous non-small cell lung cancer patients with progression-enhancing mutations following targeted therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Longer than P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 2, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2025
CompletedMay 31, 2025
May 1, 2025
2.1 years
July 29, 2019
May 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) according to RECIST 1.1
After the end of 4 cycles (15 weeks)
Secondary Outcomes (3)
The progression-free survival (PFS)
1 year
The overall survival
1 year
The duration of response
1 year
Study Arms (2)
Cohort with Bevacizumab
EXPERIMENTAL4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort without Bevacizumab
EXPERIMENTAL4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
Interventions
4 cycles of induction every 3 weeks of cisplatine,pemetrexed, atezolizumab + bevacizumab and patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed +/- Bevacizumab administered at the same dosage on 3-week cycles
Carboplatin + Pemetrexed + Atezolizumab
Eligibility Criteria
You may qualify if:
- Patient older than 18 years
- Subject affiliated to an appropriate social security system
- Signed informed consent before any trial related activities and according to local guidelines
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed, stage IIIB/IV non-squamous NSCLC (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 7th edition).
- Patient with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, osimertinib or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC. Patients with stage IIIB had to be not operable (that means not eligible for radiochemotherapy followed by a maintenance treatment by Durvalumab)
- Patient with an ALK fusion oncogene (confirmed in local laboratory) must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e., crizotinib, alectinib, ceritinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene
- Patient with a ROS1 fusion oncogene (confirmed in local laboratory) must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ROS inhibitors (i.e., crizotinib,) appropriate for the treatment of NSCLC in patients having an ROS1 fusion oncogene
- No prior chemotherapy treatment for Stage IV non-squamous NSCLC except if less than 3 cycles, with treatment free-interval of at least 1 year from C1 since last chemotherapy
- Patient who has received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from C1since the last chemotherapy, radiotherapy, or chemoradiotherapy
- Patient with an history of asymptomatic CNS metastases is eligible, provided he meets all of the following criteria:
- Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
- No ongoing requirement for corticosteroids as therapy for CNS disease
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end-organ function, defined by the following laboratory
- +1 more criteria
You may not qualify if:
- Active CNS metastases as determined by 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 \> or = 2 weeks prior to C1
- Leptomeningeal disease (Presence of cancer cells in cerebral CSF or MRI with leptomeningeal lesion strongly suspected of leptomeningeal disease )
- Uncontrolled tumour-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); Patients with indwelling catheters (e.g., PleurX) are allowed.
- Uncontrolled or symptomatic hypercalcemia (\>1.5 mmol/L ionized calcium or calcium \>12 mg/dL or corrected serum calcium \> ULN)
- Malignancies other than NSCLC within 5 years prior to C1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
- Women who are pregnant, lactating, or intending to become pregnant during the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study.
- Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen are eligible for this study
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are permitted provided that they meet the following conditions:
- Rash must cover less than 10 percent of body surface area (BSA).
- +44 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- GFPCcollaborator
Study Sites (31)
CHU
Angers, France
Centre Hospitalier
Annecy, France
CHU-Hôpital MORVAN
Brest, France
CHU Lyon Louis Pradel
Bron, France
Centre François Baclesse
Caen, 14076, France
CHU Gabriel MONTPIED
Clermont-Ferrand, France
CHIC
Créteil, France
CHU
Grenoble, France
CHU Réunion St Denis
La Réunion, France
CHU Réunion St Pierre
La Réunion, France
CHD Vendée La Roche sur Yon
La Roche-sur-Yon, France
CHU
Lille, France
CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
CHU Lyon, Croix-Rousse,
Lyon, France
Hôpital Nord
Marseille, France
CHR Orléans
Orléans, France
Hopital Foch
Paris, France
institut Curie
Paris, France
HIA Percy
Percy, France
Hôpital Haut Lévêque,Centre François Magendie
Pessac, France
CHU
Pierre-Bénite, France
CHU
Rennes, France
CHU
Rouen, France
ICLN, St Priez en Jarez
Saint-Priest-en-Jarez, France
Centre Paul Strauss
Strasbourg, France
HIA St Anne
Toulon, France
CHU
Toulouse, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
Centre Hospitalier
Villefranche, France
HIA R.Picqué
Villenave-d'Ornon, France
Related Publications (1)
Bylicki O, Tomasini P, Radj G, Guisier F, Monnet I, Ricordel C, Bigay-Game L, Geier M, Chouaid C, Daniel C, Swalduz A, Toffart AC, Doubre H, Peloni JM, Moreau D, Subtil F, Grellard JM, Castera M, Clarisse B, Martins-Lavinas PH, Decroisette C, Greillier L; GFPC. Atezolizumab with or without bevacizumab and platinum-pemetrexed in patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies: A multicentre phase II open-label non-randomised study GFPC 06-2018. Eur J Cancer. 2023 Apr;183:38-48. doi: 10.1016/j.ejca.2023.01.014. Epub 2023 Jan 31.
PMID: 36801605DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 2, 2019
Study Start
September 26, 2019
Primary Completion
October 22, 2021
Study Completion
April 9, 2025
Last Updated
May 31, 2025
Record last verified: 2025-05