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New treatment option for Lung Cancer
Official title Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
ClinicalTrials.gov ID: NCT05800587
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III...
- 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...
- 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:
You likely can't join if
- 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...
- Have not recovered from adverse events due to anticancer agents administered previously except neuropathy, alopecia or endocrinopathies that can be...
See the full eligibility 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...
- 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 \ 350 cell per μL at screening and no history of AIDS-defining opportunistic infection \< 12 months before first...
- 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...
- 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...
- 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...
- Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.