Participant flow

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). · Source last updated 2026-07-22

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

groups

1. description

   Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.

   id

   FG000

   title

   AMG 510

2. description

   Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).

   id

   FG001

   title

   Docetaxel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         85

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         39

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         45

      type

      Ongoing in study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         171

      2. group Id

         FG001

         num Subjects

         174

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         46

      type

      Switched From Docetaxel to AMG 510

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      comment

      Number of participants who have completed the study as of the primary analysis completion date (02 August 2022).

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         171

      2. group Id

         FG001

         num Subjects

         171

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Screening assessments were conducted within 28 days before Cycle 1 Day 1 (C1D1; where a cycle is 21 days). Participants were then randomized 1:1 to receive either AMG 510 or docetaxel, stratified by number of prior lines of therapy in advanced disease (1 vs 2 vs \> 2), race (Asian vs non-Asian), and history of central nervous system (CNS) involvement (present or absent).

recruitment Details

345 participants were enrolled at 148 centers in Europe, North America, Asia, Australia, and South America. The analyses presented in this results summary are based on the primary completion data. The primary completion data cut-off was 02 August 2022. The study is ongoing.

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

Preserved source evidence · Not medical advice