KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

New lung cancer treatment combines immunotherapy with other drugs before surgery

NCT: NCT06788912 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Merck Sharp & Dohme LLC · Started: 2025-03-20 · Est. Completion: 2032-02-06

Plain English Summary

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Lung Neoplasm Malignant. This study tests new drug combinations, including immunotherapy, to shrink lung cancer before surgery. It is for adults with newly diagnosed, operable non-small cell lung cancer (NSCLC) that has spread to nearby lymph nodes. Participants will receive up to 4 cycles of treatment before surgery, which may include chemotherapy and immunotherapy. Standard treatment for this condition typically involves surgery alone or surgery with chemotherapy. The trial aims to enroll 60 participants.

Official Summary

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have newly diagnosed, operable non-small cell lung cancer (NSCLC) stages II to IIIB (N2) that hasn't been treated before. You must be able to undergo surgery and have a good general health status (ECOG 0 or 1). You cannot join if you have certain types of lung cancer (e.g., superior sulcus tumors, neuroendocrine cancer), severe nerve damage, active inflammatory bowel disease, or certain heart/brain conditions. You also cannot join if you have had recent radiation, are on high-dose steroids, have active autoimmune disease, or have certain infections like Hepatitis B, Hepatitis C, or HIV. This trial is studying Lung Neoplasm Malignant, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goals are to see how many patients have no detectable cancer cells in their tumors and lymph nodes after treatment and surgery, and to measure how much the cancer shrinks. The specific primary outcome measures are: Pathological Complete Response (pCR) (Up to approximately 20 weeks); Percent Residual Viable Tumor (%RVT) (Up to approximately 20 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to improve outcomes for early-stage lung cancer by testing novel pre-surgery treatments that could potentially eliminate more cancer cells before removal. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Lung Neoplasm Malignant, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in resectable NSCLC, with potential to improve surgical outcomes and survival, making it a key area for investment in oncology. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, potential side effects, and how this treatment compares to standard options. Participation involves receiving up to 4 cycles of study treatment before surgery, followed by surgery and potentially further monitoring. You will need regular clinic visits for treatment, monitoring, and tests. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
* Able to undergo protocol therapy, including necessary surgery
* Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
* Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.

Exclusion Criteria:

* Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
* Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection.
* Known history of human immunodeficiency virus (HIV) infection.
* History of allogeneic tissue/solid organ transplant.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06788912?

NCT06788912 is a Phase 2 INTERVENTIONAL study titled "Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 60 participants.

What conditions does NCT06788912 study?

This trial investigates treatments for Lung Neoplasm Malignant. The primary condition under study is Lung Neoplasm Malignant.

What treatments are being tested in NCT06788912?

The interventions being studied include: Pembrolizumab (neoadjuvant) (BIOLOGICAL), Cisplatin (DRUG), Gemcitabine (DRUG), Pemetrexed (DRUG), Sacituzumab tirumotecan (DRUG). Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

What does Phase 2 mean for NCT06788912?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06788912?

This trial is currently "Recruiting." It started on 2025-03-20. The estimated completion date is 2032-02-06.

Who is sponsoring NCT06788912?

NCT06788912 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06788912?

The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.

How is NCT06788912 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06788912?

The primary outcome measures are: Pathological Complete Response (pCR) (Up to approximately 20 weeks); Percent Residual Viable Tumor (%RVT) (Up to approximately 20 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06788912 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Santa Barbara, California; Lone Tree, Colorado; Baltimore, Maryland and 16 more sites (United States, Chile, Greece).

Where can I find official information about NCT06788912?

The official record for NCT06788912 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06788912. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06788912 testing in simple terms?

This study tests new drug combinations, including immunotherapy, to shrink lung cancer before surgery. It is for adults with newly diagnosed, operable non-small cell lung cancer (NSCLC) that has spread to nearby lymph nodes.

Why is this trial significant?

This trial aims to improve outcomes for early-stage lung cancer by testing novel pre-surgery treatments that could potentially eliminate more cancer cells before removal.

What are the potential risks of participating in NCT06788912?

Common side effects may include fatigue, nausea, skin rash, and diarrhea. More serious risks can include severe allergic reactions, lung inflammation (pneumonitis), and effects on the heart or nervous system. There is also a risk that the treatment may not be effective or could delay surgery. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06788912?

Ask your doctor about the specific drugs being tested, potential side effects, and how this treatment compares to standard options. Participation involves receiving up to 4 cycles of study treatment before surgery, followed by surgery and potentially further monitoring. You will need regular clinic visits for treatment, monitoring, and tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06788912 signal from an investment perspective?

This trial targets a significant unmet need in resectable NSCLC, with potential to improve surgical outcomes and survival, making it a key area for investment in oncology. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive up to 4 cycles of treatment before surgery, which may include chemotherapy and immunotherapy. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.