C34 Malignant neoplasm of bronchus and lung Malignant neoplasm of bronchus and lung
Conditions
Interventions
MK-3475A, 165 mg/ml solution, 790 mg will be administered subcutaneously on day 1 of each 6-week cycle (q6w) for 18 cycles. - Pembrolizumab solution 25 mg/ml, 400 mg will be administered by intravenou
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type of Participant and Disease Characteristics Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8). Note: Mixed tumors will be characterized by the predominant cell type (squamous or nonsquamous); however, small cell elements are not permitted. Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R] AND absence of ALK and ROS1 gene rearrangements). Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations is not required. Note: The presence of a KRAS mutation in a participant’s tumor is permitted. Note: Due to insufficient sensitivity, negative ctDNA results for EGFR, ALK, and ROS1 cannot be used to satisfy this inclusion criterion. Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable (eligible for selection as target lesions) if progression has been shown in such lesions. Has provided tumor tissue before randomization that demonstrates PD-L1 expression in =50% of tumor cells (TPS =50%) as assessed by IHC at a central laboratory. Demographics An individual who is at least 18 years of age at the time of providing informed consent. Assigned Female Sex at Birth A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a POCBP OR - Is a POCBP and: - Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 120 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed. - Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5. - Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention. - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy. Informed Consent The participant has provided documented informed consent for the study. Note: Participants who are
Exclusion criteria
Exclusion criteria: Afecciones medicas Diagnostico de cancer de pulmon de celulas pequeñas o, en el caso de tumores mixtos, presencia de elementos de celulas pequeñas. Prior/Concomitant Therapy Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. Recibio tratamiento previo con un farmaco anti PD 1, anti PD L1 o anti PD L2, o con un farmaco dirigido a otro receptor de celulas T estimulador o coinhibidor (por ejemplo, CTLA 4, OX 40, CD137). Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Received prior radiotherapy within 2 weeks of start of study intervention or has radiationrelated toxicity requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to Section 6.5 for information on COVID-19 vaccines. Prior/Concurrent Clinical Study Experience Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. Diagnostic Assessments Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk earlystage prostate cancer (T1-T2a, Gleason score =6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention. Severe hypersensitivity (=Grade 3) to study intervention and/or any of its excipients. Active autoimmune disease that has required systemic treatment in the past 2 years. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Active infection requiring systemic therapy. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. K
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Welch’s t-test NAME OF THE RESULT: Area under the curve AUC0-6 wks PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During cycle 1;Welch’s t-test NAME OF THE RESULT: Minimum concentration (Cmin.) in equilibrium state PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During cycle 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Welch’s t-test NAME OF THE RESULT: Area under the curve AUC0-6 wks PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During cycle 1;Welch’s t-test NAME OF THE RESULT: Minimum concentration (Cmin.) in equilibrium state PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During cycle 3;Summary statistics with 95% CI using exact method based on binomial distribution. NAME OF THE RESULT: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent central review (BICR). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At week 6 (+7 days), week 12 (±7 days), week 18 (±7 days), q9w (±7 days) through week 45, and then q12w (±7 days) thereafter until one of the conditions for stopping tumor imaging scans is met.;Summary statistics using Kaplan-Meier method NAME OF THE RESULT: Progression-free survival (PFS) per RECIST 1.1 by BICR PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At week 6 (+7 days), week 12 (±7 days), week 18 (±7 days), q9w (±7 days) through week 45, and then q12w (±7 days) thereafter until one of the conditions for stopping tumor imaging scans is met;Summary statistics using Kaplan-Meier method NAME OF THE RESULT: Overall survival(OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from randomization to death from any cause | — |
Countries
China, Germany, Guatemala, Japan, Korea South, Peru, Poland, Romania, Spain, Turkey, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed