Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
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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