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TH-138: Phase II Randomized Trial of Carboplatin + Pemetrexed + Bevacizumab, With or Without Atezolizumab in Stage IV Non-Squamous NSCLC Patients who Harbor a Sensitizing EGFR Mutation or Have Never Smoked
While cigarette smoking remains the primary cause of most lung cancer cases, lung carcinoma in never smokers account for nearly 20 percent of cases. Never smokers with lung cancer typically present with different molecular profiles from that of smokers, which results in prognostic and therapeutic implications. Molecular changes in NSCLC that have therapeutic significance include mutations in the epidermal growth factor receptor (EGFR) and rearrangements in the anaplastic lymphoma kinase (ALK) gene. These driver mutations typically are present in lung tumors found in never or light smokers. The addition of bevacizumab to carboplatin and paclitaxel in first-line treatment of non-squamous NSCLC showed improved survival compared to carboplatin and paclitaxel alone, 12.3 vs. 10.3 months respectively. Results from the POINTBREAK trial demonstrated that carboplatin + pemetrexed + bevacizumab is an alternative option to carboplatin + paclitaxel + bevacizumab, with comparable survival but less toxicity. In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. The PD-1 inhibitor nivolumab and the PD-L1 inhibitor atezolizumab have shown prolonged survival in comparison to docetaxel in patients who previously progressed with chemotherapy, irrespective of PD-L1 expression. Thus, this study combines immunotherapeutic agent atezolozumab with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin and pemetrexed).
Primary Objective: To compare progression free survival (PFS) in patients receiving atezolizumab in addition to a platinum doublet and bevacizumab (Arm A) to those receiving a platinum doublet and bevacizumab without atezolizumab (Arm B), in stage IV non-squamous NSCLC patients who are with tumors that harbor an EGFR mutation in exon 19 or exon 21, or who are never smoker wildtypes. Secondary Objectives: To perform a safety analysis in all treated subjects. To compare the overall response rate (ORR) of Arm A to Arm B. To compare the duration of response of Arm A to Arm B. To compare the time to response of Arm A to Arm B. In the subset of patients with tumors with a known EGFR exon 19 or 21 mutation, to compare PFS and overall survival (OS) of Arm A to Arm B.
Alimta (Pemetrexed); Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); Paraplatin (carboplatin); Pemetrexed (); carboplatin ()