Dose-reduced chemotherapy for lung cancer patients with health issues

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

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.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fox Chase Cancer Center (other)
• Drugs / interventions: denosumab, immunotherapy, radiation, chemotherapy
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05800587 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility 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 this trial is running

Philadelphia, Pennsylvania

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Julia Judd, DO — Fox Chase Cancer Center
• Study coordinator: Ryan Romasko

Conditions: Lung Cancer, Small-cell Lung Cancer, Non Small Cell Lung Cancer