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Alkylating agents

Guadecitabine + Carboplatin for Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Shadia Jalal, MD, MBBS
Research Sponsored by Shadia Jalal, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS 0-1
Histological or cytological diagnosis of small cell lung cancer with extensive-stage disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of treatment start until death or date of last contact, up to a maximum of 16 months.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment on both responsive and unresponsive patients. The treatment is a combination of two drugs, and patients will receive four cycles of it.

Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer who can perform daily activities without significant assistance (ECOG PS 0-1). They must have measurable disease, adequate organ function, and agree to use effective birth control. Those pregnant or breastfeeding, with more than one prior chemotherapy line (excluding immunotherapy), or certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests a combination of Guadecitabine and Carboplatin in patients with both chemo-sensitive and chemo-resistant small cell lung cancer. Participants will receive four cycles of this treatment in an open-label, phase II clinical trial setting.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drugs, blood disorders due to bone marrow suppression by chemotherapy agents like carboplatin, liver and kidney function changes, as well as general symptoms such as fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are in good enough physical condition to carry out daily activities without limitation.
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You have been diagnosed with small cell lung cancer that has spread widely in your body.
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You have only had one round of chemotherapy before, not including immunotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of treatment start until death or date of last contact, up to a maximum of 16 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of treatment start until death or date of last contact, up to a maximum of 16 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)
Secondary outcome measures
Adverse Events
Disease Control Rate (DCR)
Objective Response Rate (ORR)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Guadecitabine and CarboplatinExperimental Treatment2 Interventions
Each cycle = 28 days; Subjects receive 4 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guadecitabine
2014
Completed Phase 3
~570
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,941 Total Patients Enrolled
Shadia Jalal, MDLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,808 Total Patients Enrolled

Media Library

Small Cell Lung Cancer Research Study Groups: Guadecitabine and Carboplatin

Frequently Asked Questions

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

What kind of indications typically prompt the prescription of this treatment?

"This therapeutic intervention is usually employed to treat melanoma, but can be useful for neoplasm metastasis, advanced directives, lymphoma and non-Hodgkin's."

Answered by AI

Is there a wide distribution of this clinical experiment in North America?

"This medical trial is running across 4 sites, including Milwaukee, Charlottesville and Muncie. To reduce travel demands for those participating in the study, it may be beneficial to opt for a site closer to you."

Answered by AI

Has this treatment received the endorsement of federal health regulatory agencies?

"Our team has awarded a safety rating of 2 to this intervention, as it is still in its second phase and possesses evidence of being safe but not yet effective."

Answered by AI

How many participants are being studied in this research project?

"At the moment, this trial is not recruiting any new participants. The study was initially posted on June 6th 2019 and had its most recent update on February 14th 2022. As an alternative, there are currently 1577 clinical trials actively enrolling small cell lung carcinoma patients and 1142 studies for this treatment seeking candidates."

Answered by AI

Are new participants currently being accepted for this clinical trial?

"Recruiting for this clinical trial is not taking place at the moment; it was first published on June 6th, 2019 and last amended on February 14th 2022. However, there are currently 1577 active studies focusing on small cell lung carcinoma and 1142 actively admitting participants to treatment trials related to this condition."

Answered by AI

To what extent has this therapeutic option been explored in prior research?

"The City of Hope Comprehensive Cancer Centre first conducted research on this therapeutic in 1997, leading to 1655 completed clinical trials. Currently, there are 1142 active studies happening primarily around Milwaukee, Wisconsin."

Answered by AI
~4 spots leftby Mar 2025