170 Participants NeededMy employer runs this trial

Gocatamig + I-DXd for Small Cell Lung Cancer

Recruiting at 52 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Platinum, Etoposide, Anti-PD-1/L1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread significantly. Researchers aim to determine if two study medicines, gocatamig and I-DXd, can effectively treat ES-SCLC, either alone or combined with standard treatments like chemotherapy and immunotherapy. Gocatamig helps T-cells (a type of white blood cell) locate and destroy cancer cells, while I-DXd delivers medicine directly to cancer cells. This trial suits individuals with a confirmed diagnosis of ES-SCLC who have not received prior systemic treatment for their condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that no prior systemic ES-SCLC treatment is allowed for certain participants, which might imply stopping some cancer treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of gocatamig and I-DXd is generally well-tolerated by patients with lung cancer. Previous studies have indicated that the safety of this combination is similar to other treatments. Some patients experienced side effects, but these were usually manageable and akin to those seen in other cancer therapies.

In one study, the combination yielded promising results, with 37% of patients experiencing tumor reduction or disappearance. This suggests that while side effects may occur, the treatment significantly impacts the cancer.

The trial under consideration is in its early stages, focusing on determining the best dose and monitoring for serious side effects. This phase is typically safe, but awareness of possible discomforts is important.

Since I-DXd is already approved for use in other lung cancer trials, this adds some confidence regarding its safety. However, discussing any concerns with the trial team and your doctor is crucial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments Gocatamig and I-DXd for small cell lung cancer because they offer a fresh approach. Unlike the standard care, which typically involves a combination of chemotherapy drugs like carboplatin, etoposide, and the immunotherapy atezolizumab, Gocatamig and I-DXd work differently by potentially targeting cancer cells more precisely. One distinctive feature is the combination of these drugs in both induction and maintenance phases, which might improve how the body fights the cancer over time. This innovative strategy could lead to better outcomes for patients with this aggressive type of lung cancer.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

This trial will evaluate the combination of gocatamig and I-DXd for treating small cell lung cancer. Studies have shown promising results for using these treatments together. Gocatamig helps the immune system attack cancer cells, while I-DXd attaches to cancer cells and delivers drugs directly to them to aid in their destruction. Research has shown that I-DXd alone can shrink or eliminate cancer in about 48% of patients with small cell lung cancer. Early data on gocatamig indicates it works in about 37% of patients. Together, these treatments aim to effectively target and reduce cancer in patients with advanced small cell lung cancer. Participants in this trial may receive gocatamig and I-DXd in different combinations, depending on their assigned treatment arm.12567

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with extensive-stage small cell lung cancer who have finished 3-4 cycles of platinum and etoposide chemo plus immunotherapy as their first treatment. Participants must not have had other treatments for ES-SCLC, certain heart or lung conditions, recent major surgery, or active infections.

Inclusion Criteria

I have not received any previous treatment for extensive-stage small cell lung cancer.
I have been diagnosed with extensive-stage small cell lung cancer.
No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
See 5 more

Exclusion Criteria

I had radiation therapy in the last 2 weeks or still need steroids for side effects.
I have had major heart or artery procedures or serious heart disease in the past 6 months.
Has history of allogeneic tissue/solid organ transplant
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive gocatamig and I-DXd or SOC (carboplatin + etoposide + atezolizumab) as initial treatment

3-4 weeks
Weekly visits for treatment administration

Maintenance

Participants continue with gocatamig and atezolizumab or atezolizumab alone until disease progression or other criteria are met

Until disease progression
Monthly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 58 months

What Are the Treatments Tested in This Trial?

Interventions

  • Gocatamig
  • I-DXd

Trial Overview

The study tests if combining two new drugs—Gocatamig (a T-cell engager) and I-DXd (an antibody drug conjugate)—with standard chemotherapy and immunotherapy can better treat advanced small cell lung cancer. The safety and effectiveness of these combinations are being compared.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumabExperimental Treatment4 Interventions
Group II: Arm 2, Parts A and B: Gocataming + I-DXdExperimental Treatment3 Interventions
Group III: Arm 1, Parts A and B: Gocataming + I-DXdExperimental Treatment3 Interventions
Group IV: Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumabActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

NCT06780137 | A Study to Evaluate the Safety and ...

This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001.

A phase 1b/2 study of gocatamig and ifinatamab ...

proteins highly expressed on the surface of small cell lung cancer (SCLC) cells1,2. • Gocatamig (MK-6070, HPN328) is a DLL3- directed T-cell ...

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small ...

These data are consistent with investigator-assessed outcomes with I-DXd in patients with SCLC in IDeate-PanTumor01 (ORR, 52.4%; median DOR, 5.9 months; median ...

Daiichi Sankyo Presents New Data in Small Cell Lung ...

Trials-in-Progress Across DXd ADC ... gocatamig and ifinatamab deruxtecan for relapsed or refractory extensive-stage small cell lung cancer.

A Study to Evaluate the Safety and Efficacy of Gocatamig ...

Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior ...

A Study to Evaluate the Safety and Efficacy of Gocatamig ...

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage ...

Press Release

The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials ...