Lung Cancer, Nonsmall Cell Clinical Trial
Official title:
Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab or Pembrolizumab With Histology-Specific Chemotherapy for Operable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | December 27, 2025 |
Est. primary completion date | August 27, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Previously untreated, histologically confirmed (by core biopsy) NSCLC and histologically confirmed stages IA3, IB and IIA NSCLC (AJCC 8th edition). - Able to undergo protocol therapy, including necessary surgery. - If female: may participate if no active pregnancy, not breastfeeding, and at least one of the following: is not a woman of childbearing potential (WOCBP), or is a WOCBP using contraceptive methods. - If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception. - ECOG 0-1 - Available formalin-fixed paraffin embedded (FFPE) tumor tissue samples Exclusion Criteria: - Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large cell neuroendocrine cancer (LCNEC) or sarcomatoid tumor. - History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority. - Has a history of (non-infectious) pneumonitis/interstitial lung disease. - Has an active infection requiring systemic therapy. - Has had an allogenic tissue/solid organ transplant. - Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients. (Refer to the respective Investigator's Brochure for a list of excipients.) - Has a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. - Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. - Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. - Has received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant erythropoietin) within 2 weeks before randomization - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). - Has received prior systemic anticancer therapy including investigational agents for the current malignancy prior to randomization/allocation. - Has received prior radiotherapy within 2 weeks of start of trial treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. - Has received a live or live attenuated vaccine within 30 days prior to the first dose of trial drug. Note: killed vaccines are allowed. - Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. - Has a known additional malignancy that is progressing or requires active treatment within the past (5 years). |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to 3 years | |
Other | Disease-free survival (DFS) | DFS is defined as the time from initial treatment to the first of the following events: disease or local progression, inability to resect tumor, local or distant recurrence, or death. | Up to 3 years | |
Other | Anatomical segmentectomy rate | Number of participants undergoing an anatomical segmentectomy will be recorded. An anatomical segmentectomy is defined as surgery based on the lung segments, 10 on the right lung, 8 on the left lung, with each segment having different morphology, size and blood vessel branch. | Up to 3 years | |
Other | Single cell RNA sequencing (scRNAseq) | scRNAseq is defined as complete transcriptomic data from tumor epithelial, stromal and immune compartments obtained from tumor samples. | Up to 3 years | |
Other | Imaging mass cytometry (IMC) panel analyses | IMC panel is performed on tumor core biopsy samples. | Up to 3 years | |
Primary | ctDNA resolution | ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathological complete response (pCR). | Up to 2 years | |
Secondary | Imaging measures of response | Imaging measures of response is defined as individual measures of response for conventional CT (quantification of response by RECIST 1.1 criteria), PET (change in standardized uptake values [SUV]) and diffusion-weighted MRI (change in apparent diffusion coefficient [ADC] obtained by image analysis software package), in correlation with pathological complete response (pCR). | Up to 3 years | |
Secondary | Pathological complete response (pCR) rate | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to 3 years | |
Secondary | Major pathological response (MPR) rate | MPR rate is defined as the percentage of participants having =10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | Up to 3 years | |
Secondary | Adverse event (AE) rate | Number of participants experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 3 years | |
Secondary | Perioperative complications rate | Number of participants experiencing perioperative complications will be recorded. | Up to 3 years |
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