Cisplatin for Carcinoma, Small Cell

Phase-Based Progress Estimates

Effectiveness

Safety

Carcinoma, Small Cell+15 More

Cisplatin - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

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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

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Pharmacological Study

Pembrolizumab

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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 - 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.

References