A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)

Study summary

This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment). Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedALRN-6924 and Carboplatin

Plus 4 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 10, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?28 U.S. locations

Locations may change over time.

Who runs it?Aileron Therapeutics, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Aileron Therapeutics, Inc.
Interventions being studied: Drug: ALRN-6924; Drug: Carboplatin; Drug: Pemetrexed; Drug: Placebo; Drug: ALRN-6924; Drug: Topotecan

Explore related studies

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)→Small cell lung cancer (SCLC)→

Treatment approach

Immunotherapy→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

Phase 1b, Part 2 NSCLC
Histopathological confirmation of Stage IV NSCLC of adenocarcinoma histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor tissue is available for p53 mutation analysis. FDA approved liquid biopsies are also acceptable.
Presence of one or more p53 mutations.
Measurable disease using RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Adequate hematological status.
Adequate hepatic and renal function. Phase 1b, Part 2 NSCLC

Reasons someone may not be able to joinExclusion criteria

Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible.
Patients who are candidates for anti-PD-1 monotherapy in 1st line advanced NSCLC (e.g. tumors with high PD-L1 expression).
Presence of active central nervous system metastases and/or carcinomatous meningitis.
Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment. Phase 1b, Part 1 SCLC Inclusion Criteria:
Histopathological confirmation of ED SCLC that has recurred or been refractory to one line of treatment with standard platinum-based chemotherapy or immuno-chemotherapy. Patients who received immunotherapy after platinum-based chemotherapy are eligible.
Presence of one or more p53 mutations.
Measurable disease using RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Adequate hematological status.
Adequate hepatic and renal function. Phase 1b, Part 1 SCLC

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

Arizona Cancer CenterKingman, Arizona
Mount Sinai Cancer Research ProgramMiami, Florida
Oncology & Hematology Associates of West BrowardTamarac, Florida
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
Regional Medical Oncolgy CenterWilson, North Carolina
Gabrail Cancer InstituteCanton, Ohio
OSHU CHO NorthwestPortland, Oregon
Gettysburg Cancer CenterGettysburg, Pennsylvania
University Clinical Center of the Republic of Srpska, Lung ClinicBanja Luka
Clinical Center University of Sarajevo, Oncology ClinicSarajevo
Charité Comprehensive Cancer Center Benjamin Franklin Hamato, OnkologischeBerlin
Universitaetsklinikum Heidelberg Thoraxklinik HeidelbergHeidelberg

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 10, 2022. Always confirm current availability with the study team.

View original record ↗