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Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 1
Started2021-12-06
View on ClinicalTrials.gov ↗

Amendment history

2026-06-26
minor
Study Status, Oversight, Eligibility v7
Eligibility criteria+1 characters
[...] um pregnancy test, throughout the study duration, and until 46 yearsmonths after the last dose of radiation. Should a woman become pre [...]
2025-05-29
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility v6
InterventionsCarboplatin (Drug), Durvalumab (Biological), Paclitaxel (Drug), Papaverine (Drug), Pemetrexed (Drug), Radiation Therapy (Radiation)→Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Durvalumab (Biological), Hypofractionated…
Eligibility criteria+84 characters
[...] 5.0) =< grade 1 (except alopecia) at the time of enrollment Absolute neutrophil count >=1.5 x 10^9/L Hemoglobin >= 9 g/dL Platelets >= 100 x 10^9/L Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN Creatinine < 1.5 mg/dL or calculated creatinine clearance* >= 50 mL/min or 24- [...] >= 18 years old Non-small cell lung cancer (NSCLC), histolog [...] mittee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease. For patients with oligometastatic [...] isease (up to 5 total sites of [...]
Primary endpoints1 entry, revised
Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT) or definitive hypofractionated radiation therapy
Study description+123 characters
[...] of papaverine (PPV) in combination with chemoradiation (CRT)/radiation andtherapy immunotherapy(RT) in patients with unresectable locally advanced (LA) non-small cell lung cancer (NSCLC) or oligometastatic NSCLC. SECONDARY OBJECTIVES: I. To estimate the rates of primary [...] ies can predict which patients may respond best to PPV + CRT/RT, and detect changes in oxygenation before and after PPV adm [...] ients receive PPV intravenously (IV) or subcutaneously (SC) over 30 minutes and patients receiving chemoradiation undergo 5 fractions of radiation therapy (RT) per week for 6 weeks or 5 fractions of hypofra [...] [...]
Collaborators+31 characters
National Cancer Institute (NCI)
2025-01-30
minor
Study Status, Oversight, Eligibility v5
Primary completion date2024-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
Eligibility criteria+601 characters
[...] (i.e. carboplatin + paclitaxel or carboplatin + pemetrexed) Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 4 years after the last dose of radiation. Should a woman become pregnant or suspect she is pregnant while she or her partn [...] Exclusion Criteria: Patients with history of pneumonectomy H [...]
2023-12-13
minor
Study Status, Study Description, Arms and Interventions, Eligibility v4
Primary completion date2023-12-31→2024-12-31
Completion date2024-12-31→2025-12-31
InterventionsCarboplatin (Drug), Durvalumab (Biological), Paclitaxel (Drug), Papaverine (Drug), Radiation Therapy (Radiation)→Carboplatin (Drug), Durvalumab (Biological), Paclitaxel (Drug), Papaverine (Drug), Pemetrexed (Drug), Radiation Therapy (Radiation)
Eligibility criteria+404 characters
[...] t Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and patients with oligometastatic disease. For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive chemoradiation to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of [...] Patients must be considered unresectable or medically-inoperable Patients with a local or regional recurrence following surgical resection for whom definitive chemoradiation to disease in the ches [...] [...]
Study description+379 characters
[...] ) and undergo 5 fractions of radiation therapy (RT) per week for 6 weeks. Patients also receive paclitaxel IV over 1 hour and carboplatin IV once weekly (QW) over 1-6 weeks or pemetrexed IV over 10 minutes followed by carboplatin IV every 3 weeks in the absence of disease progression or unacceptable toxici [...] se receive durvalumab IV every 2 weeks (Q2W) for 12 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) or CT and brain magnetic resonance imaging (MRI) during screening, and blood sample collection and CT scans throughout the trial. Patients may also under [...] [...]
2023-03-05
minor
Study Status, Contacts/Locations v3
Study sites1→2
Show 2 earlier versions
2022-04-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-03-01→confirmed 2021-12-06
Study sitesdetails revised at 1 of 1 site
2022-01-26
minor
Study Status v1
Start date2021-12-01→2022-03-01
2021-11-23
minor
Original filing
This phase I trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.
Trial Details
NCT Number NCT05136846
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Locally Advanced Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8 +1 more
Enrollment 28 participants
Start Date 2021-12-06
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30