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Part 1: NSCLC harboring NRG1+ fusion for Non-Small Cell Lung Cancer Harboring Neuregulin 1 Fusion

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
TriHealth Cancer Institute, Cincinnati, OHNon-Small Cell Lung Cancer Harboring Neuregulin 1 Fusion+1 MoreAfatinib Oral Tablet - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a new drug to treat lung and prostate cancers.

Eligible Conditions
  • Non-Small Cell Lung Cancer Harboring Neuregulin 1 Fusion
  • Metastatic Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
PF-06821497
1
Part 2 Cohort B
1
MCLA-129

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Every 8 weeks until study ends, approximately 2 years

12 months
Group A: Area under the concentration versus time curve [AUC0-∞] of afatinib when given in combination with zenocutuzumab
Afatinib
Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] afatinib when given in combination with zenocutuzumab
Afatinib
Group A: Characterize immunogenicity of zenocutuzumab.
Group A: Maximum plasma concentration [Cmax] afatinib when given in combination with zenocutuzumab
Afatinib
Year 2
Afatinib
Abiraterone acetate
Year 2
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-Specific antigen level ≥ 50% (PSA50) response.
Year 2
Antibiotics, Antineoplastic
Antibiotics, Antineoplastic
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response.
Prostate-Specific Antigen
Abiraterone acetate
Month 6
Abiraterone acetate
Month 9
Group A: Evaluate safety and tolerability of zenocutuzumab in combination with afatinib

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
PF-06821497
1
Part 2 Cohort B
1
MCLA-129

Trial Design

4 Treatment Groups

Part 1: NSCLC harboring NRG1+ fusion
1 of 4
Part 1: mCRPC
1 of 4
Part 2: NSCLC harboring NRG1+ fusion
1 of 4
Part 2: mCRPC
1 of 4

Experimental Treatment

90 Total Participants · 4 Treatment Groups

Primary Treatment: Part 1: NSCLC harboring NRG1+ fusion · No Placebo Group · Phase 2

Part 1: NSCLC harboring NRG1+ fusionExperimental Group · 2 Interventions: Afatinib Oral Tablet, MCLA-128 · Intervention Types: Drug, Biological
Part 1: mCRPCExperimental Group · 3 Interventions: Enzalutamide Pill, Abiraterone acetate tablets, MCLA-128 · Intervention Types: Drug, Drug, Biological
Part 2: NSCLC harboring NRG1+ fusionExperimental Group · 2 Interventions: Afatinib Oral Tablet, MCLA-128 · Intervention Types: Drug, Biological
Part 2: mCRPCExperimental Group · 3 Interventions: Enzalutamide Pill, Abiraterone acetate tablets, MCLA-128 · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afatinib Oral Tablet
2019
Completed Phase 2
~30
Abiraterone acetate tablets
2011
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks until study ends, approximately 2 years

Who is running the clinical trial?

Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,271 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What risks can be associated with mCRPC Phase 1?

"Although there is some evidence of safety, no clinical data exists regarding Part 1: mCRPC efficacy. Thus, it scored a 2 on our team's scale ranging from 1 to 3." - Anonymous Online Contributor

Unverified Answer

How many participants have signed up for involvement in this research?

"Affirmative, the information available from clinicaltrials.gov specifies that this scientific trial is still recruiting volunteers to participate. It was first posted on November 17th 2022 and its data set has been updated most recently on the 21st of November 2022. The research necessitates 90 participants at a single site." - Anonymous Online Contributor

Unverified Answer

What is the purpose of this experiment?

"This clinical trial seeks to assess the efficacy, safety and tolerability of Zenocutuzumab in combination with Afatinib over a two year period. Primary measurements include response rate, frequency/nature of adverse events (CTCAE Version 5.0), Area Under Curve (AUC0-∞) for afatinib and Progression-Free Survival (PFS) per RECIST v1.1 as determined by local investigators." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities currently available to participate in this research?

"Affirmative. According to the information provided on clinicaltrials.gov, this investigation is actively searching for participants and was initially posted on November 17th 2022 with a most recent update occurring four days later." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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