Chemotherapy for Lung Cancer with Other Health Conditions
This study is looking at how well lower doses of standard chemotherapy drugs like Carboplatin, Pemetrexed, Paclitaxel, Nab paclitaxel, and Docetaxel work for people with advanced lung cancer (small cell or non-small cell) who also have other health conditions. The goal is to see if these adjusted doses are effective and tolerable. You might be able to join if you have stage III or IV lung cancer and meet certain health criteria. The main way we'll know if the treatment is successful is by measuring how many patients respond to the treatment over 6 years. The study status is currently unclear, and it plans to enroll about 280 participants.
- Study design
- This is an open-label, non-randomized, single-center study, meaning everyone knows what treatment is being given, and participants are not randomly assigned to different groups. It's a Phase II study, which typically involves a smaller number of participants to evaluate effectiveness and safety.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 6 years to measure how well the treatment works.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05800587
Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentFox Chase Cancer CenterInvestigator-initiated
~280 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:CarboplatinPemetrexedPaclitaxelNab paclitaxelDocetaxelGemcitabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over 6 years
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Julia Judd, DO · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III disease who are not felt to be candidates for definitive therapy are also eligible.
Must fit into at least one of the subgroups of patients as defined in section 3.3.
Patients must have planned therapy with a regimen that includes at least one cytotoxic agent as listed in Table 1 (e.g. platinum, taxane, anti-metabolite, vinca alkaloid, podophylotoxin, camptothecin, lurbinectidin etc).
Must have measurable disease as per RECIST criteria 1.1.
History of treated or untreated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
No ongoing requirement for corticosteroids as therapy for CNS disease
No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation
Stable doses of anti-seizure medications are allowed if CNS disease has been treated and is stable. Treatment of CNS disease can include surgery, radiation or response to prior systemic therapy.
May have received prior therapy for lung cancer. There is no limit on the number of prior therapies.
Age \> 18 years
ECOG performance status of 0-3
Ability to understand and willingness to sign a written informed and HIPAA consent documents.
Females of child-bearing potential must be willing to use an effective method of contraception for the course of the study through at least 6 months after the last dose of study medication.
Patients with known HIV infection and are receiving combination antiretroviral therapy with a viral load \<400 copies per mL at screening or CD4+ T-cell count \> 350 cell per μL at screening and no history of AIDS-defining opportunistic infection \< 12 months before first dose of study drug are eligible.
Males who are fertile and who have partners who are Women of Child-bearing Potential (WOCBP) must agree to use effective method(s) of contraception as outlined in section 4.4 from the start of trial treatment, for the course of the study and 6 months after the last dose of study treatment.
Exclusion
Patients receiving only a targeted agent (e.g. TKI, sotorasib etc.) or immunotherapy without a cytotoxic agent.
Patients currently receiving investigational agents for cancer.
Patients with ECOG PS 3 and hepatic or renal dysfunction.
Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
Undergone major surgery within 28 days prior to first dose of study treatment. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
Have not recovered from adverse events due to anticancer agents administered previously except neuropathy, alopecia or endocrinopathies that can be treated with replacement therapy. Physician's discretion is allowed to decide which unresolved adverse events from previous therapy prohibit patient participation in this study.
Uncontrolled illness including, but not limited to, ongoing or active infection (other than chronic viral infections that are controlled, e.g. HIV, as described above), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (uncontrolled), cirrhosis, or psychiatric illness/ social situations that would limit compliance with the study requirements.
Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Indwelling catheters (e.g., PleurX®) are allowed.
Corrected serum Ca \> 12 mg/dl.
Patients who are receiving hypocalcemic therapies (e.g. denosumab, bisphosphonates) who achieve appropriate serum calcium levels are eligible.
Pregnant or breast feeding.
What this trial measures
- Objective response rate (ORR)6 years
To estimate the ORR including confirmed complete response (CR) and partial response (PR) rates in each treatment group 1-3