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NCT02535338 · ClinicalTrials.gov registry record · Phase 1

Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant Non-small Cell Lung Cancer

A Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
11
Enrollment target
6
Study locations

NCT02535338: Completed Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

NCT02535338 is a Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 119-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02535338, a Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target
6
Study locations

Study Summary

This phase I/II trial studies the side effects and best dose of onalespib lactate when given together with erlotinib hydrochloride and to see how well they work in treating patients with EGFR-mutant non-small cell lung cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Erlotinib hydrochloride and onalespib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Adverse events were graded by CTCAE, v4. DLTs defined as ≥Gr 3 non-hematologic toxicity except nausea, vomiting, or diarrhea that could be controlled by appropriate medical intervention or prophylaxis and that resolved within 48 hours, except electrolyte toxicities that can be corrected within 48 hours. Gr 3 rash attributed to the combination was considered a DLT if it remained Gr 3 despite maximal medical management for \> 72 hours. Hematologic toxicities qualifying as DLTs included febrile neut

Conditions Studied

Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride
  • OTHER Pharmacological Study
  • DRUG Onalespib Lactate

Study Locations (6)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Keck Medical Center of USC Pasadena - Pasadena
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • City of Hope South Pasadena - South Pasadena

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2016-04-11
Est. Completion 2021-09-08
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT02535338 record still lists

NCT02535338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 119-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Recurrent Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02535338 lists 6 locations in 1 state (California).

Frequently Asked Questions

What is clinical trial NCT02535338 about?

NCT02535338 is a clinical study titled "Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant Non-small Cell Lung Cancer". This phase I/II trial studies the side effects and best dose of onalespib lactate when given together with erlotinib hydrochloride and to see how well they work in treating patients with EGFR-mutant non-small cell lung cancer that has come back (recurrent) or has spread to other places in the body (...

What is the current status of trial NCT02535338?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-04-11. Estimated completion is 2021-09-08.

What conditions does trial NCT02535338 study?

This clinical trial studies the following conditions: Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7.

What interventions are being tested in trial NCT02535338?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG), Pharmacological Study (OTHER), Onalespib Lactate (DRUG).

Who is sponsoring clinical trial NCT02535338?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02535338 being conducted?

This trial has 6 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Lung Non-Small Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02535338's enrollment target sits among peer trials

11 28th of 30 higher than 3 of 30 other Recurrent Lung Non-Small Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Lung Non-Small Cell Carcinoma 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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Related registry views

Source: ClinicalTrials.gov NCT02535338, the US trial registry maintained by the National Library of Medicine. NCT02535338 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.