Bintrafusp Alfa With Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Locally Advanced or Metastatic Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04971187|
Recruitment Status : Terminated (PI Request)
First Posted : July 21, 2021
Last Update Posted : March 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma Metastatic Lung Non-Squamous Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Unresectable Lung Non-Squamous Non-Small Cell Carcinoma||Drug: Bintrafusp Alfa Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Phase 2 Study to Investigate Bintrafusp Alfa With Platinum-Pemetrexed for TKI-Resistant EGFR-Mutant NSCLC|
|Actual Study Start Date :||June 30, 2021|
|Actual Primary Completion Date :||February 21, 2022|
|Actual Study Completion Date :||February 21, 2022|
Experimental: Treatment (bintrafusp alfa, pemetrexed, carboplatin/cisplatin)
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Bintrafusp Alfa
- Best objective response rate [ Time Frame: Within 6 months since initiation of treatment ]Will be provided with 95% confidence intervals.
- Progression free survival (PFS) [ Time Frame: At 18 weeks since initiation of treatment ]Will be provided with 95% confidence intervals.
- Incidence of adverse events [ Time Frame: Up to 30 days post-treatment ]Adverse event data will be summarized by type, severity grade, and attribution.
- Time to resolve toxicities [ Time Frame: Up to 1 year ]
- Best response rate [ Time Frame: Up to 1 year ]
- Duration of response [ Time Frame: Up to 1 year ]
- Disease control rate [ Time Frame: Up to 1 year ]
- PFS [ Time Frame: Up to 1 year ]Cox proportional hazards regression analysis or logistic regression will be used to correlate the time-to-event endpoints such as PFS.
- Overall survival [ Time Frame: Up to 1 year ]Cox proportional hazards regression analysis or logistic regression will be used to correlate the time-to-event endpoints such as OS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971187
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Xiuning Le||M.D. Anderson Cancer Center|