Cisplatin for Carcinoma, Small Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Small Cell+15 More
Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with limited stage small cell lung cancer.

Eligible Conditions
  • Carcinoma, Small Cell
  • Stage I Lung Cancer AJCC v8
  • Malignant Neoplasms
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IB Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Small cell carcinoma of lung
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS)
Year 5
Distant metastases-free survival (DMFS)
Year 5
Progression free survival (PFS)
Month 15
Patient-reported symptomatic toxicities
Month 15
Quality of life (QoL)
Up to 2 years
Level of fatigue
Quality-adjusted survival
Up to 5 years
Blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB)
Incidence of adverse events
Local control
Objective response rate (ORR)
Time to progression

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Arm II (etoposide, cisplatin, carboplatin, radiation therapy)
1 of 2
Arm I (etoposide, cisplatin, carboplatin, radiation therapy)
1 of 2

Active Control

Experimental Treatment

545 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2 & 3

Arm I (etoposide, cisplatin, carboplatin, radiation therapy)Experimental Group · 8 Interventions: Carboplatin, 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Cisplatin, Etoposide, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Radiation, Procedure, Drug, Drug, Radiation, Other, Other
Arm II (etoposide, cisplatin, carboplatin, radiation therapy)ActiveComparator Group · 9 Interventions: Carboplatin, 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Cisplatin, Etoposide, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, Atezolizumab, Questionnaire Administration · Intervention Types: Drug, Radiation, Procedure, Drug, Drug, Radiation, Other, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Biospecimen Collection
2004
Completed Phase 1
~670
Platinum
Not yet FDA approved
Etoposide
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

NRG OncologyOTHER
216 Previous Clinical Trials
93,223 Total Patients Enrolled
4 Trials studying Carcinoma, Small Cell
749 Patients Enrolled for Carcinoma, Small Cell
National Cancer Institute (NCI)Lead Sponsor
12,993 Previous Clinical Trials
41,299,906 Total Patients Enrolled
52 Trials studying Carcinoma, Small Cell
8,928 Patients Enrolled for Carcinoma, Small Cell
Kristin A HigginsPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a positive PET/CT scan for staging within 60 days prior to registration.
Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast
You have limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.
You are eligible for this study if you have received one cycle of platinum/etoposide chemotherapy pre-registration
You must have had measurable disease prior to the required pre-registration cycle of platinum/etoposide chemotherapy.
MRI scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.