CRS Mitigation Strategies for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tri-Service General Hospital, Taipei, TaiwanSmall Cell Lung CancerCRS Mitigation Strategies - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat small cell lung cancer to see if it is safe and effective.

Treatment Effectiveness

Study Objectives

7 Primary · 11 Secondary · Reporting Duration: 24 months

12 months
Relapse Free Survival (RFS) for subjects with ED SCLC with ongoing clinical benefit following no more than 6 cycles of platinum-based chemotherapy in monotherapy arm only
24 months
Accumulation following multiple dosing for all indications
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Duration of Response (DOR) for all indications
Half-life (t1/2) following intravenous administration for all indications
Maximum observed concentration (Cmax) following intravenous administration for all indications
Minimum observed concentration (Cmin) following intravenous administration for all indications
Number of participants with clinically significant changes in vital signs for all indications
Number of participants with significant changes in ECG for all indications
Number of participants with significant changes in clinical laboratory tests for all indications
Number of participants with significant changes in physical examinations for all indications
Number of participants with treatment-emergent adverse events (AEs) for all indications
Number of participants with treatment-related AEs for all indications
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all indications
Time to Response (TTR)
6 months
Number of participants with dose limiting toxicities (DLT) for all indications
9 months
9-month Overall Survival (OS) for all indications
9-month Progression-Free Survival (PFS) for all indications

Trial Safety

Trial Design

7 Treatment Groups

Part G
1 of 7
Part D
1 of 7
Part C
1 of 7
Part F
1 of 7
Part A or Part B
1 of 7
Part A
1 of 7
Part E
1 of 7

Experimental Treatment

382 Total Participants · 7 Treatment Groups

Primary Treatment: CRS Mitigation Strategies · No Placebo Group · Phase 1

Part G
Drug
Experimental Group · 1 Intervention: AMG 757 · Intervention Types: Drug
Part DExperimental Group · 2 Interventions: CRS Mitigation Strategies, AMG 757 · Intervention Types: Drug, Drug
Part CExperimental Group · 2 Interventions: Pembrolizumab, AMG 757 · Intervention Types: Drug, Drug
Part F
Drug
Experimental Group · 1 Intervention: AMG 757 · Intervention Types: Drug
Part A or Part B
Drug
Experimental Group · 1 Intervention: AMG 757 · Intervention Types: Drug
Part A
Drug
Experimental Group · 1 Intervention: AMG 757 · Intervention Types: Drug
Part E
Drug
Experimental Group · 1 Intervention: AMG 757 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

AmgenLead Sponsor
1,301 Previous Clinical Trials
1,329,784 Total Patients Enrolled
MDStudy DirectorAmgen
843 Previous Clinical Trials
899,088 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had an organ transplant or have an active autoimmune disease that needed treatment in the last two years. This criterion only applies to Part C.
You may participate even if you have previously had brain metastases, as long as you meet certain requirements.

Frequently Asked Questions

Is participation in this medical experiment open at present?

"Affirmative. Clinicaltrials.gov conveys that this study is presently recruiting for 382 participants from 12 different medical sites, and was first announced on December 26th 2017 with its last update taking place on October 19th 2022." - Anonymous Online Contributor

Unverified Answer

How many healthcare centers are overseeing this clinical trial?

"This medical research is being conducted in 12 clinical settings, including the Ohio State University Wexner Medical Center, Washington University of Saint Louis and John Hopkins Sidney Kimmel Comprehensive Cancer Centre. The other locations are likewise specified on the study site." - Anonymous Online Contributor

Unverified Answer

What is the scope of recruitment for this investigation?

"Yes, as confirmed by the clinicaltrials.gov registry, this clinical research study is open to enrollment at 12 different sites and seeking 382 participants. The trial was initially posted on December 26th 2017 with its most recent update being October 19th 2022." - Anonymous Online Contributor

Unverified Answer

To what degree have CRS Mitigation Strategies been explored in prior research?

"Presently, 961 medical trials related to CRS Mitigation Strategies are in progress. Of those studies, 122 have progressed to Phase 3 of the trial process. While most of these trials are based out of Houston, TX, a total of 35 731 locations worldwide are involved with researching this potential treatment option." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved CRS Mitigation Strategies for use in medical treatments?

"Since this is a Phase 1 trial, with limited data affirming its safety and efficacy, CRS Mitigation Strategies was given a rating of 1." - Anonymous Online Contributor

Unverified Answer

What sorts of medical conditions are CRS Mitigation Strategies usually employed to address?

"CRS Mitigation Strategies are routinely deployed to treat malignant neoplasms, in addition to unresectable melanoma, diseases with high microsatellite instability, and chemotherapy-resistant progression." - 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.