A Phase 3 interventional study of Gocatamig and Durvalumab in Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Researchers are looking for new ways to treat limited-stage small cell lung cancer (LS-SCLC). LS-SCLC is a type of lung cancer that has not spread from the lung to other parts of the body. Researchers want to learn if gocatamig given with durvalumab can treat LS-SCLC.
The main goal of this trial is to learn if participants who receive gocatamig with durvalumab live longer without the cancer getting worse than those who receive durvalumab alone.
1,240 studies on the registry are indexed under Small Cell Lung Carcinoma; 354 are open to participants now.
This study's planned enrollment of 564 is above the median of 56 across 1,062 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,163 studies on the registry; 134 are open to participants now.
Of its 498 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
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The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Participants will receive gocatamig and durvalumab until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig · Biological: Durvalumab · Drug: Rescue Medications
Participants will receive durvalumab until documented disease progression or discontinuation criteria are met.
Biological: Durvalumab
Intravenous (IV) infusion
Also known as: MK-6070, HPN328, DS-3280
IV infusion
Also known as: IMFINZI®
Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab and/or siltuximab for treatment of cytokine release syndrome (CRS) and dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction prophylaxis.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be reported.
Time frame: Up to approximately 59 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS for participants will be reported.
Time frame: Up to approximately 87 months
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS as assessed by investigator will be reported.
Time frame: Up to approximately 87 months
Number of Participants Who Experience One or More Adverse Events (AEs)
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. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 87 months
Number of Participants Who Discontinue Study Intervention Due to an AE
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. The number of participants who discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 87 months
Mean Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 Item (EORTC QLQ-LC13) Cough (Items 31 and 32) Symptom Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants respond to the question (Item 31) "Have you coughed?" and the question (Item 32) "Have you coughed up blood?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in cough (EORTC QLQ-LC13 Items 31 and 32) scale score will be reported.
Time frame: Baseline and up to approximately 87 months
Mean Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 40) "Have you had pain in your chest?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in chest pain (EORTC QLQ-LC13 Item 40) scale score will be reported.
Time frame: Baseline and up to approximately 87 months
Mean Change From Baseline in EORTC QLQ-LC13 Dyspnea (Items 33, 34, and 35) Symptom Scale Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 33) "Were you short of breath when you rested?", the question (Item 34) "Were you short of breath when you walked?", and the question (Item 35) "Were you short of breath when you climbed stairs?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in dyspnea (EORTC QLQ-LC13 Items 33, 34, and 35) scale score will be reported.
Time frame: Baseline and up to approximately 87 months
Time to Deterioration (TTD) in EORTC QLQ-LC13 Cough (Items 31 and 32) Symptom Scale Score
EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 31) "Have you coughed?" and the question (Item 32) "Have you coughed up blood?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point deterioration (increase) in cough (Items 31 and 32), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Items 31 and 32) will be reported.
Time frame: Baseline and up to approximately 87 months
TTD in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score
EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 40) "Have you had pain in your chest?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point deterioration (increase) in chest pain (Item 40), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Item 40) will be reported.
Time frame: Baseline and up to approximately 87 months
TTD in EORTC QLQ-LC13 Dyspnea (Items 33, 34, and 35) Symptom Scale Score
EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 33) "Were you short of breath when you rested?", the question (Item 34) "Were you short of breath when you walked?", and the question (Item 35) "Were you short of breath when you climbed stairs?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point deterioration (increase) in dyspnea (Items 33, 34, and 35), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Items 33, 34, and 35) will be reported.
Time frame: Baseline and up to approximately 87 months
No study locations are listed for this record.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Gocatamig