Pembrolizumab + Investigational Agents for Lung Cancer

Recruiting at 29 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Cardiovascular disease, Autoimmune disease, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 18

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with certain types of non-small cell lung cancer that can be surgically removed. Researchers are testing the effectiveness of pembrolizumab (an immunotherapy drug) combined with other drugs to shrink or eliminate cancer before and after surgery. Participants should have untreated non-small cell lung cancer that is operable. The trial aims to determine if these treatments can eliminate cancer cells in tumors and lymph nodes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic steroids, you may need to stop or adjust them before starting the trial.

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

Research has shown that pembrolizumab is generally well-tolerated by patients. The FDA has already approved it for treating other types of cancer, providing strong safety evidence. Common side effects include tiredness, nausea, and skin rash, but these are usually manageable.

Sacituzumab tirumotecan is newer and has been tested in smaller groups. Early studies indicate it is also generally well-tolerated, though some patients have experienced side effects like low blood counts and diarrhea, which were mostly mild to moderate.

This trial combines pembrolizumab with sacituzumab tirumotecan. Early research suggests that the combination is safe for most people. The trial is in Phase 2, indicating some evidence of safety, but researchers continue to gather more data. Potential risks should always be discussed with the study team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these lung cancer treatments because they combine pembrolizumab, a well-known immunotherapy, with either a novel investigational agent or with platinum-based chemotherapy. The first treatment arm introduces sacituzumab tirumotecan, aiming to enhance the immune response against cancer cells, potentially offering a new mechanism for tackling tumors. The second arm uses a traditional platinum-based chemotherapy regimen alongside pembrolizumab, which is already a standard treatment, but the combination may improve patient outcomes by leveraging both immunotherapy and chemotherapy benefits. These approaches offer promising new ways to enhance the effectiveness of treatment before and after surgery in lung cancer patients.

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

This trial studies two different treatment combinations for non-small-cell lung cancer (NSCLC). One arm combines pembrolizumab with sacituzumab tirumotecan, which previous studies have shown to improve survival rates by more effectively targeting cancer cells. Research suggests that adding sacituzumab tirumotecan to pembrolizumab after surgery could help remove more cancer cells. Another arm explores pembrolizumab combined with platinum-based chemotherapy, which is under investigation for its potential to shrink tumors before surgery. This trial explores both combinations to determine if they can reduce or eliminate cancer cells in tumors and lymph nodes, leading to better patient outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with resectable non-small cell lung cancer. Participants should be suitable for surgery and have not received prior systemic therapy for their lung cancer. Specific details on inclusion or exclusion criteria are not provided.

Inclusion Criteria

The main inclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pembrolizumab and chemotherapy prior to surgery

12 weeks

4 cycles of treatment every 3 weeks

Surgery

Participants undergo surgical resection of the tumor

1 week

1 surgical visit

Adjuvant Treatment

Participants receive pembrolizumab post-surgery for 13 cycles

39 weeks

13 cycles of treatment every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

Trial Overview The study tests Pembrolizumab combined with other agents like Cisplatin, Carboplatin, Gemcitabine, etc., before (neoadjuvant) and after (adjuvant) surgery. The aim is to see if the treatment clears cancer cells from tumors and lymph nodes during surgery.

How Is the Trial Designed?

Group I: Pembrolizumab + Sacituzumab tirumotecan Experimental Treatment 13 Interventions

Neoadjuvant: Prior to surgery pembrolizumab 200 mg Q3W for 4 cycles (each cycle is 21 days); sacituzumab tirumotecan 4 mg/kg Q2W for 6 cycles (each cycle is 14 days), followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days). Optional adjuvant platinum-based doublet chemotherapy up to 4 cycles may be given at the investigator's discretion.

Group II: Pembrolizumab + Platinum Active Control 7 Interventions

Neoadjuvant: Prior to surgery pembrolizumab 200 mg every three weeks (Q3W) for 4 cycles (each cycle is 21 days); Cisplatin 75 mg/m\^2 Q3W with gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or paclitaxel 175 mg/m\^2 or 200 mg/m\^2 q3w (any histology) OR Carboplatin AUC 5 mg/mL• min or AUC 6 mg/mL• min with paclitaxel 175 mg/m\^2 or 200 mg/m\^2 Q3W (any histology), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors); followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days).

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06312137

NCT06312137 | A Study to Assess Efficacy and Safety of ... This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving ...

2. jto.org jto.org/article/S1556-0864(24)01578-8/fulltext

P4.11D.02 Phase 3 Trofuse-007 Study The TroFuse-007 study will evaluate the efficacy and safety of the addition of sac-TMT to pembrolizumab vs pembrolizumab alone in patients with previously ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11948873/

Recent advances in therapeutic strategies for non-small cell ... Both targeted therapy and immunotherapy have significantly improved the survival of patients with metastatic non-small-cell lung cancer (NSCLC).

4. uclahealth.org uclahealth.org/clinical-trials/study-assess-efficacy-and-safety-pembrolizumab-with-or

A Study to Assess Efficacy and Safety of Pembrolizumab ... This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10213

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and ... This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20584396

Clinical Trials The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to ...