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NCT04216316 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Squamous Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
12
Enrollment target
20
Study locations

NCT04216316: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Squamous Carcinoma, sponsored by National Cancer Institute (NCI).

NCT04216316 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Squamous Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04216316, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Squamous Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
20
Study locations

Study Summary

This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving berzosertib together with carboplatin, gemcitabine, and pembrolizumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and pembrolizumab alone.

Primary Outcome

Percentage of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0

Conditions Studied

Stage IV Lung Cancer AJCC v8 Lung Non-Small Cell Squamous Carcinoma

Interventions

  • DRUG Carboplatin
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Gemcitabine Hydrochloride
  • DRUG Berzosertib

Study Locations (20)

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • HaysMed - Hays
  • University of Kansas Cancer Center - Kansas City
  • Lawrence Memorial Hospital - Lawrence
  • Olathe Health Cancer Center - Olathe
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • University of Kansas Hospital-Indian Creek Campus - Overland Park
  • Ascension Via Christi - Pittsburg - Pittsburg
  • Salina Regional Health Center - Salina
  • University of Kansas Health System Saint Francis Campus - Topeka
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

California

  • Keck Medicine of USC Koreatown - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami

Missouri

  • Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-04-14
Est. Completion 2025-04-12
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04216316 still lists

NCT04216316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (88% lower).

The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04216316 names 20 study sites across 4 states, led by Kansas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04216316 about?

NCT04216316 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer". This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib...

What is the current status of trial NCT04216316?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-04-14. Estimated completion is 2025-04-12.

What conditions does trial NCT04216316 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Squamous Carcinoma.

What interventions are being tested in trial NCT04216316?

The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG).

Who is sponsoring clinical trial NCT04216316?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04216316 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04216316's enrollment target sits among peer trials

12 72nd of 81 higher than 9 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04216316, the US trial registry maintained by the National Library of Medicine. NCT04216316 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.