Pembrolizumab + Investigational Agents for Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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

Trial Timeline

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment13 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 + PlatinumActive Control7 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 (D1) and Dy 8 (D8) 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 D1 and D8 Q3W (squamous tumors); followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days) .