Study of MK-6070 drug combination in first-line extensive-stage small cell lung cancer patients

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What is this study about?

The study focuses on people diagnosed with Small cell lung cancer extensive stage and evaluates two investigational medicines, MK-6070 and Ifinatamab Deruxtecan, which are given by intravenous infusion. The purpose is to determine how safe the treatments are and how effectively they can shrink or stop the growth of the cancer.

Participants receive a series of IV infusions over several weeks and attend regular clinic visits for physical examinations, blood tests, and imaging scans that allow doctors to see the size of the tumor. Throughout the trial, any side effects, including serious reactions that might limit the dose, are recorded, and the change in tumor size is monitored to assess response. The study continues until sufficient information on safety and tumor response has been collected.

1 baseline assessments

after joining the study, you will undergo a series of baseline assessments to record your health status. this includes a medical history interview, physical examination, blood tests, and imaging scans to evaluate the extent of small cell lung cancer.

the results of these assessments establish a reference point for later comparisons during the trial.

2 initial treatment infusion

the first intravenous infusion will be administered in the clinic. you will receive the study drugs, which may include mk-6070 (gocatamig), ifinatamab deruxtecan, and atezolizumab. the exact dose and volume are determined by the study protocol and prepared by qualified staff.

the infusion is given over a set period of time while you are monitored for immediate reactions.

3 repeated treatment cycles

subsequent treatment cycles are scheduled according to the protocol, typically repeating the intravenous infusion of the study drugs at regular intervals (for example, every three weeks). each cycle follows the same procedure as the initial infusion.

the number of cycles continues until disease progression, unacceptable side effects, or completion of the planned treatment period.

4 safety monitoring visits

before each infusion, you will have safety monitoring visits that include blood tests, vital sign checks, and a review of any symptoms you have experienced.

the study team will assess for adverse events and dose-limiting toxicities, which are side effects that may require modification or discontinuation of the study drugs.

5 efficacy assessments

periodically, imaging scans are performed to evaluate how the tumor responds to the treatment. the primary measure is the objective response rate, which reflects tumor shrinkage according to standardized criteria.

these assessments help determine whether the regimen is effective for your cancer.

6 treatment continuation or adjustment

if the treatment is well tolerated and the disease has not progressed, you will continue receiving the same regimen.

if significant side effects occur, the study protocol may allow dose adjustments, temporary pauses, or substitution with alternative agents such as etoposide or carboplatin as defined by the investigators.

7 end of treatment

treatment ends when the study protocol criteria are met, which may be due to disease progression, unacceptable toxicity, or completion of the planned number of cycles.

you will be informed of the reason for treatment discontinuation and advised on next steps.

8 post‑treatment follow‑up

after stopping the study drugs, you will continue to have follow‑up visits for several months. these visits include clinical evaluations, laboratory tests, and imaging to monitor overall survival and disease status.

the follow‑up schedule is defined by the study protocol and may extend beyond the active treatment period.

Who Can Join the Study?

You must have a confirmed diagnosis of extensive‑stage small cell lung cancer (ES‑SCLC). This means doctors have looked at tissue or cells under a microscope to be sure of the cancer type.
If you will receive the maintenance treatment with gocatamig plus I‑DXd, you must have already finished 3 to 4 cycles of platinum‑based chemotherapy with etoposide and an approved anti‑programmed cell death 1/ligand 1 (anti‑PD‑1/L1) immunotherapy as your first‑line treatment, and this must have been completed within the past 6 weeks.
For those receiving the maintenance regimen above, there must be no sign that the cancer has gotten worse on imaging tests, as judged by the RECIST 1.1 criteria (a standard set of rules doctors use to measure tumor size on scans).
You must not have had any other systemic (whole‑body) therapy for extensive‑stage small cell lung cancer before joining the study.
If you have already received a “rechallenge” therapy (a repeat of a previous treatment), you are not eligible for the study.
If you will receive gocatamig + I‑DXd in induction and maintenance (or similar combinations), you must not have had any prior systemic treatment for extensive‑stage small cell lung cancer.
Having had limited‑stage small cell lung cancer in the past is allowed only if at least 6 months have passed since that treatment ended and the cancer later progressed.
You must be able to provide a tumor tissue sample, either from an existing archived sample or from a new core, incisional, or excisional biopsy of a tumor that has not been treated with radiation before.
Your cancer must be measurable on scans according to RECIST 1.1, meaning doctors can see and measure the tumors. Tumors that were previously irradiated can still be measured if they have grown since radiation was completed.
You must be an adult (usually 18 years or older) and can be male or female.

Who Cannot Join the Study?

Pleural effusion, pericardial effusion, or ascites that need repeated draining procedures – fluid buildup around the lungs, heart, or in the abdomen that must be removed often.
History of receiving an allogeneic tissue or solid organ transplant – having a donor organ or tissue transplanted into the body.
History of leptomeningeal disease – cancer that has spread to the thin membranes covering the brain and spinal cord.
Infection with human immunodeficiency virus (HIV) and a past diagnosis of Kaposi’s sarcoma or Multicentric Castleman’s Disease – specific cancers that can occur with HIV.
Previous treatment with drugs that block PD‑1, PD‑L1, or PD‑L2 or other medicines that affect T‑cell receptors – therapies that target certain immune system pathways.
Radiation therapy received within 2 weeks before starting the study, or lingering radiation side effects that need corticosteroids (steroid medicines).
Any other cancer that is getting worse or needed active treatment in the past 3 years.
Active autoimmune disease that required systemic (whole‑body) medication in the past 2 years, except for simple hormone replacement.
Known active cancer spread to the central nervous system (CNS) (brain or spinal cord) or carcinomatous meningitis – cancer involvement of the brain’s covering membranes.
Major surgery within 4 weeks or minor surgery within 2 weeks before randomization, or a planned major surgery during the study.
Any history of interstitial lung disease (ILD) or pneumonitis (lung inflammation), current ILD, or suspected ILD that cannot be ruled out by scans.
Severe lung problems caused by other ongoing lung illnesses.
History of significant bleeding in the brain (intracranial) or spinal cord.
Active neurologic paraneoplastic syndrome – nerve problems caused by the cancer’s effect on the nervous system.
History of heart or blood‑vessel surgery such as coronary or peripheral artery bypass graft, angioplasty, or serious heart disease (heart attack, symptomatic congestive heart failure, uncontrolled irregular heartbeat) within 6 months before the first dose.
Other uncontrolled or serious heart or blood‑vessel disease as defined by the study protocol.
History of a blood clot in an artery (arterial thrombosis) within 6 months before the first dose.
Presence of chronic liver disease.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
University General Hospital Of Heraklion	Heraklion	Greece
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Henry Dunant Hospital Center	Athens	Greece
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Lyybf Gtxrkka Hehrygoo Ov Azfngg	Athens	Greece
Hdzbtfus Vovy dkhrbech	Barcelona	Spain
Uectvstwca Hnsbrkwu Cyjzxiz	Cologne	Germany
Corqbd Hfqdsmmxcwm Es Umzemiwgdhyka Dw Lyumnwb	Limoges	France
Ifihfnie Rgjdkhxqf Pxb Li Silbiu Dgf Twhinw Djzz Arnoftt Iovs Scimrg	Meldola	Italy
Ajyfvj Marbanf Csqqpt Seva	Thessaloniki	Greece
Nmwvfljt Iyhttfdh Obvtmumbc Iih Muebp Snhhkvljdvqcwlvcchlyjqqcjszb Ieaeskbu Bpmxzbnk	Cracow	Poland
Uaewgmfvrsbxtniwnxhdb Wbjqfauxj Aau	Wuerzburg	Germany
Uglnvgqtszpzgd Cqunkry Kkrscwqhh	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	06.04.2026
Germany	Recruiting	06.04.2026
Greece	Recruiting	06.04.2026
Italy	Recruiting	06.04.2026
Poland	Not yet recruiting	06.04.2026
Spain	Recruiting	06.04.2026

Trial locations

Investigated Drugs:

Atezolizumab is an immunotherapy drug given by IV infusion. It works by helping the body’s immune system recognize and attack cancer cells. In this study it is one of the experimental treatments being tested for safety and how well it works in patients with extensive‑stage small cell lung cancer.

Tocilizumab is a medication that blocks a protein called interleukin‑6, which can reduce inflammation. In this trial it is used as a background therapy, meaning it is given to all participants to help manage side effects that may arise from the other cancer treatments.

Etoposide is a chemotherapy drug given by IV infusion. It works by interfering with the DNA inside cancer cells, which stops them from growing and dividing. In this study it serves as a comparator, allowing researchers to compare the new treatments against a standard chemotherapy option.

Carboplatin is another chemotherapy drug given by IV infusion. It damages the DNA of cancer cells, helping to stop their growth. Like etoposide, it is used as a comparator in the trial to see how the new regimens stack up against established chemotherapy.

Ifinatamab Deruxtecan (also called I‑DXd) is a targeted antibody‑drug conjugate delivered through IV infusion. It combines an antibody that seeks out cancer cells with a chemotherapy payload that is released directly into those cells. In this trial it is part of the experimental regimens being evaluated for safety and effectiveness.

MK-6070 is an investigational drug given by IV infusion. It is designed to work with the immune system to fight cancer, though the exact way it helps is still being studied. In this study it is tested in different combinations with Ifinatamab Deruxtecan to see how well the pair works and how safe it is for patients.

Small cell lung carcinoma, extensive stage – It is a fast‑growing cancer that begins in the lining of the airways in the lung. In the extensive stage, cancer cells have spread beyond the original lung to distant sites such as the opposite lung, lymph nodes, liver, bone, or brain. The disease spreads rapidly through the bloodstream and lymphatic system, forming new tumor nodules. As the tumor burden increases, symptoms like cough, shortness of breath, and fatigue become more pronounced. Over time, the involvement of multiple organs leads to further decline in function.

Trial ID:

2025-521032-11-00

Protocol code:

MK-6070-003

NCT ID:

NCT07227597

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of MK-6070 drug combination in first-line extensive-stage small cell lung cancer patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?