Trial Title:
Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
NCT ID:
NCT05800587
Condition:
Lung Cancer
Small-cell Lung Cancer
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Paclitaxel
Etoposide
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Irinotecan
Pemetrexed
Topotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Intervention type:
Drug
Intervention name:
Lurbinectedin
Description:
Standard of care chemotherapy regimen
Arm group label:
Platinum doublet plus immunotherapy (IO)
Arm group label:
Platinum doublet with or without a VEGFi
Arm group label:
Single agent chemotherapy with or without a VEGFi
Summary:
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.
Detailed description:
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. The investigator will indicate the
rationale(s) for dose modification based on the subgroups of patients listed in the
protocol. Patients may fit into multiple subgroups and this is accounted for in the
prospectively defined dose reduction level as listed in the protocol. Prespecified doses
by chemotherapeutic agent and dose level adjustment based on patient characteristics and
comorbidities are listed in the protocol. Analyses will be stratified by treatment group
1-3 based on the treating physician's selected therapy.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan Romasko
Phone:
267-838-8380
Email:
ryan.romasko@fccc.edu
Investigator:
Last name:
Julia Judd, DO
Email:
Principal Investigator
Start date:
February 22, 2023
Completion date:
August 1, 2029
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800587
