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NCT03786692 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC
A Phase 2 study of Non-Small Cell Carcinoma of Lung, TNM Stage 4, sponsored by Fox Chase Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
- 1
- Study location
NCT03786692 is a Phase 2 study of Non-Small Cell Carcinoma of Lung, TNM Stage 4 that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 117 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03786692, a Phase 2 study of Non-Small Cell Carcinoma of Lung, TNM Stage 4, is actively recruiting participants, sponsored by Fox Chase Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG Arm A
- DRUG Arm B
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03786692
The ClinicalTrials.gov registry entry for NCT03786692 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Carcinoma of Lung, TNM Stage 4 appearing as the primary indexed condition, and to 2 interventions - of which Arm A is the first listed.
NCT03786692 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03786692 about?
NCT03786692 is a clinical study titled "Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC". 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 im...
What is the current status of trial NCT03786692?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2019-09-04. Estimated completion is 2028-01.
What conditions does trial NCT03786692 study?
This clinical trial studies the following conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4.
What interventions are being tested in trial NCT03786692?
The interventions under investigation include: Arm A (DRUG), Arm B (DRUG).
Who is sponsoring clinical trial NCT03786692?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03786692 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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