Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Dose-reduced chemotherapy for lung cancer patients with health issues

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

Run by Fox Chase Cancer Center · NCT05800587 · Data updated 2026-11-12

This study is testing if a lower dose of chemotherapy can help lung cancer patients with other health issues feel better and manage their treatment safely.

More Lung Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment280 (estimated)
SponsorFox Chase Cancer Center
Academic / other
Drugs / interventionsdenosumab, immunotherapy, radiation, chemotherapy
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedFebruary 22, 2023
Main results expectedAugust 1, 2028
Study endsAugust 1, 2029
Registry record updatedMay 22, 2026
Trial IDNCT05800587 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with stage IV lung cancer or stage III lung cancer not eligible for definitive therapy, who also have comorbidities.

Probably not a fit

Patients with early-stage lung cancer or those who do not have any comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized, single-center phase II study aims to evaluate the efficacy, toxicity, and tolerability of dose-attenuated chemotherapy regimens in lung cancer patients who have comorbidities. The study will involve patients with stage IV lung cancer or stage III patients not suitable for definitive therapy, who will receive tailored chemotherapy based on their individual health profiles. The treatment regimens include various cytotoxic agents, and dose modifications will be made according to predefined criteria. The study will analyze outcomes based on different treatment groups as determined by the treating physician.

Why it matters

Potential benefit: If successful, this approach could improve treatment tolerability and outcomes for lung cancer patients with additional health challenges.

How similar studies have gone: Other studies have shown promise with dose-modified chemotherapy approaches in similar patient populations, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.