CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
Carboplatin +5 moredrug
Likely dose
Nivolumab and/or ipilimumab combined with carboplatin or cisplatin plus docetaxel or pemetrexed (specific doses not stated in INTERVENTIONS)AI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed previously untreated non-small cell lung cancer (neuroendocrine carcinomas excluded; carcinomas with neuroendocrine differentiation allowed)
  • Stage IA, IB, IIA, IIB, or IIIA disease (AJCC 7th edition); Stage IA/IB <4 cm eligible for arms A/B only; Stage IB ≥4 cm, IIA, IIB, IIIA eligible for all arms
  • Stage IIIA patients must have no more than one mediastinal lymph node station involved by tumor
  • Lymph node evaluation of contralateral stations 2 and/or 4 required to exclude N3 disease
Key exclusion· 12
  • Prior systemic therapy or radiation therapy for current lung cancer
  • Currently receiving cancer therapy (chemotherapy, radiation, immunotherapy, biologic therapy) or investigational anti-cancer drug
  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody
  • Pregnant or lactating women; women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to nivolumab initiation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158129
NCT03158129Phase 2Completed

Phase II Study of Induction Checkpoint Blockade for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection

M.D. Anderson Cancer Center·interventional·Posted May 17, 2017·Updated Apr 6, 2026

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Cisplatin, and 4 other interventions for Stage I Lung Non-Small Cell Cancer AJCC v7 and 6 related conditions. Completed, enrolled 101 participants across 1 site.

Detailed Summary

This phase II trial studies how well nivolumab works when given alone and in combination with ipilimumab or chemotherapy in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, docetaxel, and pemetrexed, 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 with ipilimumab or chemotherapy may work better in treating patients with non-small cell lung cancer compared to chemotherapy alone.

Study Details

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartJun 16, 2017
Primary CompletionNov 13, 2024
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 9.1 years ago

Interventions

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Docetaxeldrug

Given IV

Ipilimumabbiological

Given IV

Nivolumabbiological

Given IV

Pemetrexeddrug

Given IV