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Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

NCT02093962 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2025-05-16

Study results available
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Summary

The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.

Conditions

Interventions

DRUG

TH-302 combination with pemetrexed

400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle. Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.

DRUG

Matched placebo in combination with pemetrexed

Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle. Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • ImmunoGenesis

    lead INDUSTRY

Principal Investigators

  • Tillman Pearce, MD · Threshold Pharmaceuticals

  • Jonathan Goldman, MD · UCLA-Dept of Medicine a Div of Hem/Onc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • United States
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT02093962 on ClinicalTrials.gov