Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Pemetrexed Disodium — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Dec 20, 2017

Status verified

Feb 2026

Primary completion

Dec 6, 2020

Completion

Feb 8, 2023

Study Design

Enrollment

14 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (nivolumab, cisplatin, pemetrexed disodium)
  Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
• Experimental: Cohort I (nivolumab, cisplatin, gemcitabine hydrochloride)
  Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Major Pathologic Response (mpCR) Defined as < 10% Viable Tumor [ Time Frame: Up to 63 days ]

Locations (2)

Related coverage on Hipa.ai

• Nivolumab Plus Chemotherapy Shows High Pathologic Response in Resectable NSCLC
  Nivolumab · Feb 20, 2026 · ClinicalTrials.gov

Find similar trials in Abington, PA