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NCT03965689 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy

A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
27
Enrollment target
10
Study locations

NCT03965689: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

NCT03965689 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (72% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03965689, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
27 participants
Enrollment target
10
Study locations

Study Summary

This phase II trial studies how well MLN4924 (pevonedistat), carboplatin, and paclitaxel work in treating patients with stage IIIB or IV non-small cell lung cancer. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat together with carboplatin and paclitaxel may work better in treating patients with non-small cell lung cancer when compared with other standard chemotherapy drugs.

Primary Outcome

Response will be evaluated at the time all participants completed treatment and using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Patients will be re-evaluated for response every 6 weeks. Overall response is the best response achiev

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Unresectable Lung Non-Small Cell Carcinoma Metastatic Lung Non-Squamous Non-Small Cell Carcinoma Metastatic Lung Non-Small Cell Squamous Carcinoma Unresectable Lung Non-Squamous Non-Small Cell Carcinoma

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • DRUG Pevonedistat

Study Locations (10)

California

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

Florida

  • Moffitt Cancer Center-International Plaza - Tampa
  • Moffitt Cancer Center - McKinley Campus - Tampa
  • Moffitt Cancer Center - Tampa

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Wisconsin

  • University of Wisconsin Carbone Cancer Center - University Hospital - Madison

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2020-04-16
Est. Completion 2026-03-18
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03965689 still lists

NCT03965689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 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 (72% lower).

The record links to 8 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.

NCT03965689 lists 10 locations in 6 states (California, Florida, District of Columbia).

Frequently Asked Questions

What is clinical trial NCT03965689 about?

NCT03965689 is a clinical study titled "Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy". This phase II trial studies how well MLN4924 (pevonedistat), carboplatin, and paclitaxel work in treating patients with stage IIIB or IV non-small cell lung cancer. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as ca...

What is the current status of trial NCT03965689?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2020-04-16. Estimated completion is 2026-03-18.

What conditions does trial NCT03965689 study?

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

What interventions are being tested in trial NCT03965689?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Pevonedistat (DRUG).

Who is sponsoring clinical trial NCT03965689?

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

Where is trial NCT03965689 being conducted?

This trial has 10 study locations across California, District of Columbia, Florida, New Jersey, Ohio. 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 NCT03965689's enrollment target sits among peer trials

27 55th of 81 higher than 27 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 NCT03965689, the US trial registry maintained by the National Library of Medicine. NCT03965689 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.