A Phase 1/2 interventional study of Gocatamig and I-DXd in Small Cell Lung Cancer Extensive Stage, sponsored by Merck Sharp & Dohme LLC. Recruiting at 58 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 12 studies in Small Cell Lung Carcinoma by Merck & Co., Inc — 3 open to participants now, 8 under way, 3 of them phase 3. Small Cell Lung Carcinoma · Merck & Co., Inc.
Among the 12 studies in Small Cell Lung Carcinoma by Merck & Co., Inc, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 4 in phase 1/2, and was the 11th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.
Browse Small Cell Lung Carcinoma studies →3 of the 12 studies in Small Cell Lung Carcinoma by Merck & Co., Inc are open now, in 12 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 9 more countries
Ages 18+
Merck Sharp & Dohme LLC
Ages 18+
By country, each count listing its studies:
Of the 265 Small Cell Lung Carcinoma studies recruiting now, 175 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 4
First in 2011; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 170 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 280 across the 12 interventional studies. Of the 4 that completed or were terminated, 4 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
2 of the studies in Small Cell Lung Carcinoma by Merck & Co., Inc that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04624204Phase 3Merck Sharp & Dohme LLCPlacebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) | 2027-10-28 |
| NCT02628067Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158) | 2027-05-04 |
Add all 2 to your calendar (.ics) → With an account.
Among the 12 studies in Small Cell Lung Carcinoma by Merck & Co., Inc, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
The goals of this study are to learn:
In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1/ligand 1 protein (anti-PD-1/L1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DXd in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Drug: Gocatamig · Drug: I-DXd · Drug: Rescue Medications
Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.
Drug: Gocatamig · Drug: I-DXd · Drug: Rescue Medications
Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Drug: Gocatamig · Drug: I-DXd · Drug: Atezolizumab · Drug: Rescue Medications
Participants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Drug: Atezolizumab · Drug: Carboplatin · Drug: Etoposide
Intravenous (IV) administration
Also known as: MK-6070, HPN328, DS-3280
IV administration
Also known as: MK-2400, DS-7300a
IV administration
IV administration
IV administration
Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.
Number of Participants Who Experience an Adverse Event (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 experience an AE will be reported.
Time frame: Up to approximately 58 months
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT criteria. The number of participants who experience at least one DLT will be presented.
Time frame: Up to approximately 21 days
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 58 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 58 months
Disease Control Rate (DCR)
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD). The DCR as assessed by BICR will be presented.
Time frame: Up to approximately 58 months
Duration of Response (DOR)
For participants who demonstrate a confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 58 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization (Part B for Arms 2-4) or from the first dose of study treatment (safety run-in Part A and Arm 1 Part B) to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. 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 BICR will be presented.
Time frame: Up to approximately 58 months
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment (Part A and Arm 1 Part B) or randomization (Part B for Arms 2-4) to death due to any cause.
Time frame: Up to approximately 58 months
Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig
Blood samples will be collected at multiple time points to determine the AUCt of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
AUCt of I-DXd
Blood samples will be collected at multiple time points to determine the AUCt of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
AUCt of Deruxtecan (DXd)
DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt of the drug payload DXd.
Time frame: At designated time points (up to approximately 58 months)
AUCt of Anti-B7-H3 Antibody
Blood samples will be collected at multiple time points to determine the AUCt of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig
Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
AUCt,ss of I-DXd
Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
AUCt,ss of DXd
DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug payload DXd.
Time frame: At designated time points (up to approximately 58 months)
AUCt,ss of Anti-B7-H3 Antibody
Blood samples will be collected at multiple time points to determine the AUCt,ss of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Maximum Concentration (Cmax) of Gocatamig
Blood samples will be collected at multiple time points to determine Cmax of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Cmax of I-DXd
Blood samples will be collected at multiple time points to determine Cmax of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
Cmax of DXd
DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Cmax of the drug payload DXd.
Time frame: At designated time points (up to approximately 58 months)
Cmax of Anti-B7-H3 Antibody
Blood samples will be collected at multiple time points to determine Cmax of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Trough Concentration (Ctrough) of Gocatamig
Blood samples will be collected at multiple time points to determine Ctrough of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Ctrough of I-DXd
Blood samples will be collected at multiple time points to determine Ctrough of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
Ctrough of DXd
DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Ctrough of the drug payload DXd.
Time frame: At designated time points (up to approximately 58 months)
Ctrough of Anti-B7-H3 Antibody
Blood samples will be collected at multiple time points to determine Ctrough of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig
Blood samples will be collected at multiple time points to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.
Time frame: At designated time points (up to approximately 58 months)
Incidence of ADAs Against I-DXd
Blood samples will be collected at multiple time points to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.
Time frame: At designated time points (up to approximately 58 months)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Jan 2026 (actual). Primary completion is estimated for Nov 2030, 58 months after the start.
Of 71 industry-sponsored phase 1/2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 74. This study's planned 58 months is close to that.
Counting every sponsor, half of 98 studies reached it within 54 months; a quarter within 44 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Gocatamig · Ifinatamab deruxtecan