NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.

Detailed description

This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities. The investigator will indicate the rationale(s) for dose modification based on the subgroups of patients listed in the protocol. Patients may fit into multiple subgroups and this is accounted for in the prospectively defined dose reduction level as listed in the protocol. Prespecified doses by chemotherapeutic agent and dose level adjustment based on patient characteristics and comorbidities are listed in the protocol. Analyses will be stratified by treatment group 1-3 based on the treating physician's selected therapy.

Conditions

• Lung Cancer
• Small-cell Lung Cancer
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Standard of care chemotherapy regimen
DRUG	Pemetrexed	Standard of care chemotherapy regimen
DRUG	Paclitaxel	Standard of care chemotherapy regimen
DRUG	Nab paclitaxel	Standard of care chemotherapy regimen
DRUG	Docetaxel	Standard of care chemotherapy regimen
DRUG	Gemcitabine	Standard of care chemotherapy regimen
DRUG	Etoposide	Standard of care chemotherapy regimen
DRUG	Irinotecan	Standard of care chemotherapy regimen
DRUG	Topotecan	Standard of care chemotherapy regimen
DRUG	Lurbinectedin	Standard of care chemotherapy regimen

Timeline

• Start date: 2023-02-22
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2023-04-05
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study