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Immunotherapy

Cisplatin for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization up to data cut off (assessed up to 27 months)
Awards & highlights

Study Summary

This trial is testing a new immunotherapy drug, M7824, to see if it is safe and effective when used with standard chemotherapy and radiation therapy to treat people with cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization up to data cut off (assessed up to 27 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization up to data cut off (assessed up to 27 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Secondary outcome measures
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824
Number of Participants With Positive Antidrug Antibodies (ADA)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: cCRT plus M7824 followed by M7824Experimental Treatment7 Interventions
Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
Group II: cCRT plus placebo followed by durvalumabActive Control8 Interventions
Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~40
Cisplatin
FDA approved
M7824
2020
Completed Phase 2
~350
Etoposide
FDA approved

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,707 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,469 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,845 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Cisplatin for medical utilization?

"The safety of Cisplatin has been evaluated as a 2 on the 1 to 3 scale. This is because, while there is some data affirming its security profile, it lacks clinical evidence demonstrating efficacy at this stage in development."

Answered by AI

In what circumstances is Cisplatin typically recommended?

"Cisplatin is a popular remedy for metastatic ureter urothelial carcinoma, but it also has applications in the treatment of lymphoma, non-Hodgkin's Merkle cell cancer, and locally advanced cases of non-small cell lung cancer."

Answered by AI

Is this research endeavor actively seeking participants?

"Clinicialtrials.gov's data shows that, as of October 7th 2021, this trial is no longer actively recruiting patients. It first opened for enrollment on April 16th 2019 and has since not been updated. However, there are 3,886 other studies currently seeking volunteers to join trials around the world."

Answered by AI

How many healthcare centers are facilitating this clinical experiment?

"BC Cancer Agency Centre for the Southern Interior in Kelowna, Mayo Clinic Rochester and Holy Cross Hospital - Michael & Dianne Bienes CCC in Fort Lauderdale are some of 22 sites involved with this trial."

Answered by AI

How many volunteers are involved in this experiment?

"Unfortunately, this trial is no longer receiving new participants. It was first announced on April 16th 2019 and the last update took place October 7th 2021. Nevertheless, there are currently 1949 active studies for people with carcinoma non-small cell lung cancer and 1937 trials recruiting patients who use Cisplatin."

Answered by AI

Has Cisplatin been studied for any other medical purposes?

"The City of Hope Comprehensive Cancer Center first undertook a study on cisplatin back in 1997. Since then, there have been over 21006 completed studies and 1937 trials that are still underway - many of these happening in Kelowna, Minnesota."

Answered by AI
~26 spots leftby Mar 2025