RecruitingPhase 2NCT03786692

Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC

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


Sponsor

Fox Chase Cancer Center

Enrollment

117 participants

Start Date

Sep 4, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (atezolizumab) to a standard three-drug chemotherapy regimen (carboplatin, pemetrexed, and bevacizumab) improves outcomes for patients with advanced non-squamous non-small cell lung cancer that carries specific gene mutations. **You may be eligible if...** - You have been diagnosed with stage IV non-squamous non-small cell lung cancer confirmed by biopsy or lab test - Your tumor has a specific mutation in the EGFR gene (in exon 19 or 21), OR you are a non-smoker without ALK, ROS1, or EGFR mutations **You may NOT be eligible if...** - Your cancer is a squamous cell type - Your tumor has ALK or ROS1 gene rearrangements (unless you are in the never-smoker wild-type group) - You have already received treatment for advanced disease - You have other conditions that would interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArm A

Carboplatin + Pemetrexed + Bevacizumab + Atezolizumab

DRUGArm B

Carboplatin + Pemetrexed + Bevacizumab


Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT03786692


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