Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer

NCT03366766 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-02-20

Study results available
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Summary

This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Cisplatin and Pemetrexed Disodium or Gemcitabine Hydrochloride, 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. Giving Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride may work better in treating patients with non-small cell lung cancer.

Conditions

  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Stage I Non-Small Cell Lung Cancer
  • Stage IA Non-Small Cell Lung Carcinoma
  • Stage IB Non-Small Cell Lung Carcinoma
  • Stage II Non-Small Cell Lung Cancer
  • Stage IIA Non-Small Cell Lung Carcinoma
  • Stage IIB Non-Small Cell Lung Carcinoma
  • Stage IIIA Non-Small Cell Lung Cancer

Interventions

BIOLOGICAL

Nivolumab

Given IV

DRUG

Cisplatin

Given IV

DRUG

Pemetrexed Disodium

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Rita Axelrod, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2020-12-06
Completion
2023-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03366766 on ClinicalTrials.gov