Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Led by Fox Chase Cancer Center · Updated on 2025-04-04

280

Participants Needed

1

Research Sites

336 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed stage IV lung cancer (small cell or non-small cell) or stage III disease not suitable for definitive therapy
  • Fits into at least one predefined patient subgroup based on comorbidities
  • Planned therapy includes at least one cytotoxic chemotherapy agent as listed in the protocol
  • Measurable disease according to RECIST criteria 1.1
  • History of treated or untreated asymptomatic CNS metastases meeting specific stability criteria
  • May have had prior lung cancer therapy with no limit on number of prior treatments
  • Age over 18 years
  • ECOG performance status between 0 and 3
  • Able to understand and willing to sign informed consent and HIPAA documents
  • Females of child-bearing potential agree to use effective contraception during the study and for 6 months after last dose
  • Males with partners who are women of child-bearing potential agree to use effective contraception during the study and for 6 months after last dose
  • Patients with controlled HIV infection meeting viral load and CD4 count criteria
Not Eligible

You will not qualify if you...

  • Receiving only targeted therapy or immunotherapy without cytotoxic agents
  • Currently receiving investigational cancer treatments
  • ECOG performance status of 3 with liver or kidney dysfunction
  • Clinical signs of gastrointestinal obstruction or need for parenteral hydration/nutrition
  • Major surgery within 28 days before treatment or planned major surgery during the trial
  • Not recovered from previous anticancer therapy adverse events except certain manageable conditions
  • Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, uncontrolled arrhythmia, cirrhosis, or psychiatric/social issues limiting compliance
  • Leptomeningeal disease
  • Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
  • Corrected serum calcium above 12 mg/dl
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

R

Ryan Romasko

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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