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NCT02991651 · ClinicalTrials.gov registry record · Phase 1
Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC
A Phase 1 study, sponsored by Io Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02991651: Clinical Trial Phase 1 study, sponsored by Io Therapeutics.
NCT02991651 is a Phase 1 study that was terminated before completion, run by Io Therapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02991651, a Phase 1 study, was terminated before completion, sponsored by Io Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Patient selection: a) Pathological confirmation of non-small cell lung cancer without activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion) with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant women are excluded; e) Informed consent. Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging evaluation including CT-chest or PET/CT scan; Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using intra-patient dose escalation for dose levels 1 and 2. These study agents will be administered orally until progression of disease, unacceptable toxicities, activation of a phase II study of the combination, or exhaustion of the IRX4204 drug supply. Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.
Primary Outcome
To determine the recommended phase II dose (RP2D) for the combination of IRX4204 and erlotinib.
Interventions
- DRUG erlotinib
- DRUG IRX4204
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2025-05-09 |
| Phase | Phase 1 |
Why NCT02991651 stopped before completion
NCT02991651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which erlotinib is the first listed.
NCT02991651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02991651 about?
NCT02991651 is a clinical study titled "Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC". Patient selection: a) Pathological confirmation of non-small cell lung cancer without activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion) with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant women are excluded; e) Informed...
What is the current status of trial NCT02991651?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-12-07. Estimated completion is 2025-05-09.
What interventions are being tested in trial NCT02991651?
The interventions under investigation include: erlotinib (DRUG), IRX4204 (DRUG).
Who is sponsoring clinical trial NCT02991651?
This trial is sponsored by Io Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02991651's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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