Small Cell Lung CancerPhase 3NCT07908537
A Clinical Trial of Gocatamig (MK-6070) With Durvalumab in Participants With Small Cell Lung Cancer (MK-6070-004)
A Phase 3 study testing Gocatamig, Durvalumab and Rescue Medications in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Gocatamig, Durvalumab and Rescue Medications
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2026to 10 Mar 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) defined as Stage I-III by American Joint Committee on Cancer 9th Edition Cancer Staging
- Has received appropriate definitive concurrent chemoradiotherapy (CRT; 4 cycles of platinum-based chemotherapy concurrent with radiotherapy) per protocol
- Has achieved complete response, partial response, or stable disease and did not progress per protocol following definitive, platinum-based chemotherapy concurrent with radiotherapy
- Is not expected to require tumor resection during the study
- Is able to submit a biopsy of a tumor lesion not previously irradiated
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- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART), if diagnosed with HIV
- Has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy, if hepatitis B surface antigen-positive
- Has undetectable hepatitis C virus (HCV) viral load, if has a history of HCV infection
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has received sequential CRT for LS-SCLC (no overlap of radiotherapy with chemotherapy)
- Has clinical or radiographic progression or deterioration while on concurrent CRT
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Has active or history of immune deficiency (with the exception of well-controlled HIV on ART)
- Has history of Kaposi's sarcoma and/or Multicentric Castleman's Disease, if diagnosed with HIV
Show all 18Show fewer
- Is expected to require any other form of antineoplastic therapy while on study
- Has known additional malignancy that is progressing or required active treatment within the past 3 years
- Has known central nervous system metastases or leptomeningeal disease
- Has active autoimmune disease that required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy (other than therapies permitted per protocol)
- Has active or history of neurologic paraneoplastic syndrome
- Has current pneumonitis/interstitial lung disease (ILD) or history of noninfectious pneumonitis/ILD that required steroids
- Has uncontrolled or significant cardiovascular disease
- Has clinically severe pulmonary compromise from intercurrent pulmonary illnesses
- Has history of clinically significant intracranial or spinal cord bleeding
- Has history of allogeneic tissue/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
About this study
Official title: A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) in Combination With Durvalumab Compared to Durvalumab Alone as Consolidation Therapy in Participants With Limited-Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Gocatamig, Durvalumab, Rescue Medications
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GocatamigBiological
Also called MK-6070, HPN328, DS-3280
Intravenous (IV) infusion
DurvalumabBiological
Also called IMFINZI®
IV infusion
Rescue MedicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gocatamig and durvalumab | Experimental | Participants will receive gocatamig and durvalumab until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig; Biological: Durvalumab; Drug: Rescue Medications |
| Durvalumab | Active comparator | Participants will receive durvalumab until documented disease progression or discontinuation criteria are met. Receives: Biological: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 59 months
Secondary outcomes (10)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS for participants will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to approximately 87 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start7 Dec 2026 (estimated)
- Primary completion8 Dec 2031 (estimated)
- Study completion10 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908537
- Sponsor's protocol ID
- 6070-004
- Other IDs
- MK-6070-004
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) in Combination With Durvalumab Compared to Durvalumab Alone as Consolidation Therapy in Participants With Limited-Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
- ClinicalTrials.gov ID
- NCT07908537
- Acronym / sponsor ID
- 6070-004
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 7 Dec 2026 (estimated)
- Primary completion
- 8 Dec 2031 (estimated)
- Study completion
- 10 Mar 2036 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gocatamig and durvalumab | Experimental | Biological: Gocatamig, Biological: Durvalumab, Drug: Rescue MedicationsParticipants will receive gocatamig and durvalumab until documented disease progression or discontinuation criteria are met. |
| Durvalumab | Active comparator | Biological: DurvalumabParticipants will receive durvalumab until documented disease progression or discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) defined as Stage I-III by American Joint Committee on Cancer 9th Edition Cancer Staging
- Has received appropriate definitive concurrent chemoradiotherapy (CRT; 4 cycles of platinum-based chemotherapy concurrent with radiotherapy) per protocol
- Has achieved complete response, partial response, or stable disease and did not progress per protocol following definitive, platinum-based chemotherapy concurrent with radiotherapy
- Is not expected to require tumor resection during the study
- Is able to submit a biopsy of a tumor lesion not previously irradiated
Key exclusion criteria (18 listed)
- Has received sequential CRT for LS-SCLC (no overlap of radiotherapy with chemotherapy)
- Has clinical or radiographic progression or deterioration while on concurrent CRT
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Has active or history of immune deficiency (with the exception of well-controlled HIV on ART)
- Has history of Kaposi's sarcoma and/or Multicentric Castleman's Disease, if diagnosed with HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GocatamigAlso: MK-6070, HPN328, DS-3280Intravenous (IV) infusion | Biological | Gocatamig and durvalumab |
| DurvalumabAlso: IMFINZI®IV infusion | Biological | Durvalumab, Gocatamig and durvalumab |
| Rescue MedicationsParticipants 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. | Drug | Gocatamig and durvalumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 59 months
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.
10 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 87 months
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to approximately 87 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 87 months
Number of Participants Who Discontinue Study Intervention Due to an AE
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
Time frame: Baseline and up to approximately 87 months
Mean Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score
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
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
Time frame: Baseline and up to approximately 87 months
TTD in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score
Time frame: Baseline and up to approximately 87 months
TTD in EORTC QLQ-LC13 Dyspnea (Items 33, 34, and 35) Symptom Scale Score
Time frame: Baseline and up to approximately 87 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gocatamig, Durvalumab and Rescue Medications in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to approximately 59 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.