MK-7684A-006: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK-7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC
Brief description of study
This trial is testing MK-7684A when given in combination with chemotherapy plus radiation therapy (concurrent chemoradiotherapy or cCRT). This trial is for people with stage 3 non-small cell lung cancer (NSCLC). Receiving cCRT is part of the standard treatment for patients with stage 3 NSCLC. MK-7684A, an experimental treatment, is an immunotherapy.
Detailed description of study
Once the participant has been consented, participant will be randomized to one of 2 study groups. Group A will receive MK-7684A plus cCRT for the first 9 weeks, then receive MK-7684A alone for the next 51 weeks. Group B will receive cCRT for the first 9 weeks, then receive Durvalumab for the next 52 weeks. The provider will determine which chemotherapy the participant will receive.
This study is currently Enrolling by Invitation at Lancaster General Hospital - ABBCI.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-Small Cell Lung
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion
- Pathologically confirmed diagnosis of NSCLC
- The primary tumor is considered unresectable and is pathologically confirmed Stage IIIA, IIIB, or IIIC NSCLC independent of the mediastinal lymph nodes.
- Presence or absence of metastases in the mediastinal lymph nodes would not change the radiotherapy plan.
- Is determined to have unresectable, Stage III NSCLC
- No evidence of metastatic disease
- Has measurable disease defined by RECIST 1.1
- Provided tumor tissue sample
- ECOG Performance of 0 or 1 assessed within 7 days prior to the first administration of study intervention
- Life expectancy <6 months
- Has adequate PFT
Exclusions
- Medical conditions: SCLC or tumors with presence of small cell elements
- Prior/Concomitant Therapy
- Prior/Concurrent clinical study experience
- Diagnostic assessments: immunodeficiency, malignancy, severe hypersensitivity, active autoimmune disease, history of pneumonitis/interstitial lung disease, active infection requiring systemic therapy, known history of HIV, known history of Hepatitis B, psychiatric or substance abuse disorder
- Allogenic tissue/solid organ transplant
- Meals/dietary restrictions
