Non Small Cell Lung CancerPhase 1NCT04022876
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
A Phase 1 study testing ALRN-6924, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Aileron Therapeutics, Inc. at 28 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- What is being tested?
- ALRN-6924, Carboplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 3 Sep 2019to 30 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Phase 1b, Part 2 NSCLC Inclusion Criteria:
- 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 Exclusion 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 Exclusion Criteria:
- More than one line of prior chemotherapy for ED SCLC (prior immunotherapy is permitted, concurrent with or subsequent to first line chemotherapy).
- Presence of active central nervous system metastases and/or carcinomatous meningitis.
- Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment.
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States8 sites
Gabrail Cancer Institute
Canton, Ohio, 44718
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Arizona Cancer Center
Kingman, Arizona, 86409
Mount Sinai Cancer Research Program
Miami, Florida, 33140
OSHU CHO Northwest
Portland, Oregon, 97210
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Regional Medical Oncolgy Center
Wilson, North Carolina, 27893
Italy6 sites
Istituto Romagnolo per lo Studio dei Tumori, Dino Amadori
Meldola
Azienda Ospedaliero, Universitaria di Modena, Policlinico di Modena
Modena
Istituto Nazionale Tumori di Napoli, IRCCS, Fondazione, G. Pascale
Naples
Università degli Studi di Pavia, IRCCS, Fondazione, Policlinico San Matteo
Pavia
Azienda Unità Sanitaria Locale della Romagna, Ospedale Santa Maria delle Croci
Ravenna
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Germany4 sites
Charité Comprehensive Cancer Center Benjamin Franklin Hamato, Onkologische
Berlin
Universitaetsklinikum Heidelberg Thoraxklinik Heidelberg
Heidelberg
LMU Klinikum der Universitaet Muenchen, Respiratory Medicine and Thoracic Oncology, Campus Innenstandt
München
München Klinik Neuperlach, Klinik für Hamatologie und Onkologie, Studienburo Neuperlach/Harlaching
München
Serbia4 sites
CHC Bezanijska Kosa
Belgrade
University Clinical Centre of Serbia, Pulmonology Clinic
Belgrade
Clinical Centre Nis, Clinic for Pulmonary Diseases
Niš
Institute for Pulmonary Diseases of Vojvodina
Novi Sad
Spain3 sites
Hospital Clinico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
MD Anderson Cancer Center
Madrid
Bosnia and Herzegovina2 sites
University Clinical Center of the Republic of Srpska, Lung Clinic
Banja Luka
Clinical Center University of Sarajevo, Oncology Clinic
Sarajevo
About this study
Official title: A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
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.
Read the detailed description
During Part 1 SCLC, topotecan will be administered per standard practice on Days 1-5 of 21-day cycles. Patients will be randomized to receive 1 of 2 initial ALRN-6924 dose levels, to be administered prior to each planned topotecan dose. The incidence, severity and duration of hematologic toxicities, including neutropenia, thrombocytopenia, and febrile neutropenia, will be determined. The safety and tolerability of each ALRN-6924 dose level will be assessed during Part 1. ALRN-6924 is given either 24 hr or 6 hr prior to each topotecan administration.
Part 2 NSCLC of the study will be conducted in two stages. In Stage 1, a total of 20 patients will be randomized 1:1 to receive (with or without immunotherapy) either carboplatin plus pemetrexed plus ALRN-6924 or carboplatin plus pemetrexed plus placebo.
During Stage 1 of Part 2 NSCLC, two interim analyses will be conducted after 10 and 20 patients, respectively, have been evaluated. The purpose of the two interim analyses is to confirm safety and exclude futility. In Stage 2 of Part 2 NSCLC, an additional 40 patients will be randomized to treatment as described for Stage 1.
Immunotherapy and/or bevacizumab may be used concurrently with chemotherapy and after completion of 1st-line treatment (i.e., for maintenance purposes) as per local standard of care. Time of administration of immunotherapy and/or bevacizumab relative to chemotherapy will follow local standards of care.
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Being tested
- ALRN-6924, Carboplatin, Pemetrexed, Placebo, Topotecan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALRN-6924Drug
ALRN-6924 administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.
CarboplatinDrug
Carboplatin administered IV on Day 1 of every 21-day cycle.
PemetrexedDrug
Pemetrexed administered IV on Day 1 of every 21-day cycle.
PlaceboDrug
Placebo administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.
ALRN-6924Drug
ALRN-6924 administered IV on Days 0-4 prior to topotecan administered IV on Days 1-5 of every 21-day cycle.
TopotecanDrug
Topotecan administered IV on Days 1-5 of every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed | Experimental | Not described Receives: Drug: ALRN-6924; Drug: Carboplatin; Drug: Pemetrexed |
| Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed | Experimental | Not described Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Placebo |
| Part 1 SCLC: ALRN-6924+Topotecan | Experimental | Not described Receives: Drug: ALRN-6924; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b Part 2 NSCLC
Proportion of completed treatment cycles that are free of Grade ≥ 3 hematological toxicities (including neutropenia, anemia, thrombocytopenia and febrile neutropenia), and free of chemotherapy dose reductions, and free of use of growth factors and transfusions.
Measured: Approximately 6 months
Phase 1b Part 1 SCLC
Proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs)
Measured: Approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start3 Sep 2019
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Why it stopped: With a favorable safety profile the difference between treatment groups for the primary composite endpoint was not sufficient to generate statistically significant results with the targeted sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aileron Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022876
- Sponsor's protocol ID
- ALRN-6924-1-03
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2019
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
- ClinicalTrials.gov ID
- NCT04022876
- Acronym / sponsor ID
- ALRN-6924-1-03
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: With a favorable safety profile the difference between treatment groups for the primary composite endpoint was not sufficient to generate statistically significant results with the targeted sample size
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Aileron Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During Part 1 SCLC, topotecan will be administered per standard practice on Days 1-5 of 21-day cycles. Patients will be randomized to receive 1 of 2 initial ALRN-6924 dose levels, to be administered prior to each planned topotecan dose. The incidence, severity and duration of hematologic toxicities, including neutropenia, thrombocytopenia, and febrile neutropenia, will be determined. The safety and tolerability of each ALRN-6924 dose level will be assessed during Part 1. ALRN-6924 is given either 24 hr or 6 hr prior to each topotecan administration.
Part 2 NSCLC of the study will be conducted in two stages. In Stage 1, a total of 20 patients will be randomized 1:1 to receive (with or without immunotherapy) either carboplatin plus pemetrexed plus ALRN-6924 or carboplatin plus pemetrexed plus placebo.
During Stage 1 of Part 2 NSCLC, two interim analyses will be conducted after 10 and 20 patients, respectively, have been evaluated. The purpose of the two interim analyses is to confirm safety and exclude futility. In Stage 2 of Part 2 NSCLC, an additional 40 patients will be randomized to treatment as described for Stage 1.
Immunotherapy and/or bevacizumab may be used concurrently with chemotherapy and after completion of 1st-line treatment (i.e., for maintenance purposes) as per local standard of care. Time of administration of immunotherapy and/or bevacizumab relative to chemotherapy will follow local standards of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed | Experimental | Drug: ALRN-6924, Drug: Carboplatin, Drug: Pemetrexed |
| Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed | Experimental | Drug: Carboplatin, Drug: Pemetrexed, Drug: Placebo |
| Part 1 SCLC: ALRN-6924+Topotecan | Experimental | Drug: ALRN-6924, Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALRN-6924ALRN-6924 administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle. | Drug | Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed |
| CarboplatinCarboplatin administered IV on Day 1 of every 21-day cycle. | Drug | Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed, Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed |
| PemetrexedPemetrexed administered IV on Day 1 of every 21-day cycle. | Drug | Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed, Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed |
| PlaceboPlacebo administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle. | Drug | Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed |
| ALRN-6924ALRN-6924 administered IV on Days 0-4 prior to topotecan administered IV on Days 1-5 of every 21-day cycle. | Drug | Part 1 SCLC: ALRN-6924+Topotecan |
| TopotecanTopotecan administered IV on Days 1-5 of every 21-day cycle. | Drug | Part 1 SCLC: ALRN-6924+Topotecan |
Primary outcome
Phase 1b Part 2 NSCLC
Time frame: Approximately 6 months
Proportion of completed treatment cycles that are free of Grade ≥ 3 hematological toxicities (including neutropenia, anemia, thrombocytopenia and febrile neutropenia), and free of chemotherapy dose reductions, and free of use of growth factors and transfusions.
Phase 1b Part 1 SCLC
Time frame: Approximately 19 months
Proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs)
Results and safety
The study was stopped early (reason given: With a favorable safety profile the difference between treatment groups for the primary composite endpoint was not sufficient to generate statistically significant results with the targeted sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALRN-6924, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Aileron Therapeutics, Inc. at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Italy, Germany, Serbia, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: With a favorable safety profile the difference between treatment groups for the primary composite endpoint was not sufficient to generate statistically significant results with the targeted sample size). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b Part 2 NSCLC (time frame: Approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.