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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date: Jan 2026 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 117 to confirmed 107
    • Site details revised
    v14
  2. Minor Site contact updatedv13
  3. Notable Primary completion date: Jan 2025 to Jan 2026
    • Study completion date: Jan 2027 to Jan 2028
    v12
  4. Notable Primary completion date: Jan 2024 to Jan 2025
    • Study completion date: Jan 2026 to Jan 2027
    v11
  5. Notable Primary completion date: Jan 2023 to Jan 2024
    • Study completion date: Jan 2025 to Jan 2026
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary completion date: Jan 2022 to Jan 2023
    • Study completion date: Jan 2024 to Jan 2025
    • Eligibility criteria expanded, about 25 words
    v9
  2. Minor 2 versions Re-verified since Oct 7, 2020, no change to tracked fieldsv7-v8
  3. Minor Eligibility criteria expanded, about 491 wordsv6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2019 to Sep 4, 2019
    • Collaborators expanded, about 4 words
    v5
  5. Notable Start date: Feb 2019 to Sep 2019v4
  6. Minor Eligibility criteria expanded, about 13 wordsv3
  7. Minor Study title shortened, about 8 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03786692
Lead Sponsor Fox Chase Cancer Center
Collaborators: National Comprehensive Cancer Network
Conditions
(from sponsor)
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov