Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
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| ClinicalTrials.gov Identifier: NCT04303780 |
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Recruitment Status :
Active, not recruiting
First Posted : March 11, 2020
Results First Posted : May 10, 2023
Last Update Posted : May 10, 2023
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
KRAS p, G12c Mutated /Advanced Metastatic NSCLC |
| Interventions |
Drug: AMG 510 Drug: Docetaxel |
| Enrollment | 345 |
Participant Flow
| 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. |
| 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). |
| Arm/Group Title | AMG 510 | Docetaxel |
|---|---|---|
 Arm/Group 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. | 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). |
| Period Title: Overall Study | ||
| Started | 171 | 174 |
| Switched From Docetaxel to AMG 510 | 0 | 46 |
| Completed [1] | 0 | 3 |
| Not Completed | 171 | 171 |
| Reason Not Completed | ||
| Death | 104 | 85 |
| Lost to Follow-up | 5 | 2 |
| Withdrawal by Subject | 12 | 39 |
| Ongoing in study | 50 | 45 |
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[1]
Number of participants who have completed the study as of the primary analysis completion date (02 August 2022).
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Baseline Characteristics
| Arm/Group Title | AMG 510 | Docetaxel | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle. | 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). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 171 | 174 | 345 | |
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Baseline Analysis Population Description |
As pre-specified in the statistical analysis plan, data are presented for all randomized participants according to original treatment assignment, regardless of whether participants switched from receiving docetaxel to receiving AMG 510.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 171 participants | 174 participants | 345 participants | |
| 63.4 (9.9) | 63.6 (9.1) | 63.5 (9.5) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 171 participants | 174 participants | 345 participants | |
| Female |
62 36.3%
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79 45.4%
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141 40.9%
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| Male |
109 63.7%
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95 54.6%
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204 59.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 171 participants | 174 participants | 345 participants | |
| Hispanic or Latino |
5 2.9%
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9 5.2%
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14 4.1%
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| Not Hispanic or Latino |
165 96.5%
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163 93.7%
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328 95.1%
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| Unknown or Not Reported |
1 0.6%
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2 1.1%
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3 0.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 171 participants | 174 participants | 345 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
21 12.3%
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22 12.6%
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43 12.5%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
2 1.2%
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0 0.0%
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2 0.6%
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| White |
142 83.0%
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144 82.8%
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286 82.9%
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| More than one race |
1 0.6%
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0 0.0%
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1 0.3%
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| Unknown or Not Reported |
5 2.9%
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8 4.6%
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13 3.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Amgen Inc. |
| Phone: | 866-572-6436 |
| EMail: | medinfo@amgen.com |
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT04303780 |
| Other Study ID Numbers: |
20190009 2019-003582-18 ( EudraCT Number ) |
| First Submitted: | March 5, 2020 |
| First Posted: | March 11, 2020 |
| Results First Submitted: | April 17, 2023 |
| Results First Posted: | May 10, 2023 |
| Last Update Posted: | May 10, 2023 |