Participant flow

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) · Source last updated 2026-07-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].

   id

   FG000

   title

   NAC + Neoadjuvant/Adjuvant Pembrolizumab

2. description

   Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].

   id

   FG001

   title

   NAC + Neoadjuvant/Adjuvant Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         141

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         276

      2. group Id

         FG001

         num Subjects

         247

      type

      Ongoing in study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         397

      2. group Id

         FG001

         num Subjects

         400

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         396

      2. group Id

         FG001

         num Subjects

         399

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         397

      2. group Id

         FG001

         num Subjects

         400

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 797 participants that were randomized to trial, 795 received treatment. At the time of the primary analysis data cut-off, 523 participants are ongoing in the study.

recruitment Details

Adult participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC) were recruited to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\].

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice