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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTH-302 combination with pemetrexed and Matched placebo in combination with pemetrexed

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 16, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?80 U.S. locations

Locations may change over time.

Who runs it?ImmunoGenesis

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: ImmunoGenesis
Interventions being studied: Drug: TH-302 combination with pemetrexed; Drug: Matched placebo in combination with pemetrexed

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Men and women ≥ 18 years of age.
Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology
Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated \< 12 months prior to study randomization will be counted as one prior treatment
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment
Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment
Measurable disease according to RECIST 1.1
ECOG performance status 0-1
Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy
Adequate hematologic, hepatic, cardiac, and renal function
Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution

Reasons someone may not be able to joinExclusion criteria

Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS
Prior therapy with pemetrexed
Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL \<80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing
Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met:
brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery
steroids are currently not required and more than 14 days since last steroid treatment
Symptomatic pleural effusion (\> CTCAE Grade 1 dyspnea) that is not amenable to drainage
Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
Elective or a planned major surgery while on study treatment
Radiation therapy to greater than 25% of the bone marrow
Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
Pregnant or breast feeding
Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
Patients who are taking medications that are strong inducers or inhibitors of CYP3A4

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

UAB Cancer CenterBirmingham, Alabama
Ironwood Cancer and Research CentersChandler, Arizona
California Cancer CenterEncinitas, California
California Cancer Center AssociatesFresno, California
UCLA-Department of Medicine a Division of Hem/OncLos Angeles, California
Sarcoma Oncology Research CenterSanta Monica, California
VA Eastern Colorado Healthcare SystemDenver, Colorado
Christiana Care Health ServicesNewark, Delaware
Cancer Specialists of North Florida - CBOJacksonville Beach, Florida
AMPM ResearchMiami, Florida
Research Medical CenterKansas City, Kansas
Ochsner Clinical FoundationNew Orleans, Louisiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 16, 2025. Always confirm current availability with the study team.

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