Asset profile

Sotorasib

Small molecule

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Acceleratedaccelerated approval

Evidence outlook

Accelerated approval: Non-Small Cell Lung Cancer (label: locally advanced or metastatic NSCLC with KRAS G12C mutation following at least one prior systemic...)

Accelerated approval is granted on surrogate endpoints; confirmatory clinical benefit is being verified in ongoing trials. Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

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Competitive landscape

69 competitors in this universe: 9 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Sotorasib: this drugApprovedSmall moleculeKRAS G12C
CalderasibPhase 3Small moleculeKRAS G12C
DivarasibPhase 3Small moleculeKRAS G12C
FulzerasibPhase 3Small moleculeKRAS G12C
GlecirasibPhase 3Small moleculeKRAS G12C
JMKX001899Phase 3Small moleculeKRAS G12C
ElironrasibPhase 1/2Small moleculeKRAS G12C
FMC-376Phase 1/2Small moleculeKRAS G12C
BBO-8520Phase 1Small moleculeKRAS G12C
HBI-2438Phase 1Small moleculeKRAS G12C
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A

…and 54 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(24 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (4)
October 2026 (1)
Phase 1Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2026-10-31 · NCT06333951 · CT.gov ↗
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November 2026 (1)
Phase 1Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8 …Recruiting
Est. primary completion 2026-11-24 · NCT06249282 · CT.gov ↗
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December 2026 (2)
Phase 1Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C MutationActive not recruiting
Est. primary completion 2026-12-17 · NCT04185883 · CT.gov ↗
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Phase 2Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 …Active not recruiting
Est. primary completion 2026-12-31 · NCT04625647 · CT.gov ↗
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2027 (11)
April 2027 (1)
Phase 1Advanced Solid Tumors Harboring KRAS G12C MutationRecruiting
Est. primary completion 2027-04-26 · NCT06659341 · CT.gov ↗
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May 2027 (1)
Phase 2Colorectal Cancer, Resectable Colorectal CarcinomaRecruiting
Est. primary completion 2027-05 · NCT05845450 · CT.gov ↗
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June 2027 (2)
Phase 1/2Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8 …Recruiting
Est. primary completion 2027-06-14 · NCT07012031 · CT.gov ↗
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Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-06-30 · NCT05920356 · CT.gov ↗
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August 2027 (3)
Phase 1Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-08 · NCT05815173 · CT.gov ↗
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Phase 2Non Small Lung CancerRecruiting
Est. primary completion 2027-08 · NCT06582771 · CT.gov ↗
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Phase 1Advanced Solid TumorsRecruiting
Est. primary completion 2027-08-01 · NCT06804824 · CT.gov ↗
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October 2027 (1)
Phase 2Lung CancerActive not recruiting
Est. primary completion 2027-10-20 · NCT05118854 · CT.gov ↗
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November 2027 (1)
Phase 1Dynamic Tumor Resistance, Metastatic Colorectal CancerNot yet recruiting
Est. primary completion 2027-11-14 · NCT07318389 · CT.gov ↗
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December 2027 (2)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-12-12 · NCT05631249 · CT.gov ↗
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Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-12-31 · NCT05398094 · CT.gov ↗
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2028 (4)
January 2028 (1)
Phase 1Brain TumorRecruiting
Est. primary completion 2028-01 · NCT06807619 · CT.gov ↗
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July 2028 (1)
Phase 2Advanced Solid TumorsRecruiting
Est. primary completion 2028-07-01 · NCT07172919 · CT.gov ↗
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September 2028 (1)
Phase 3Metastatic Colorectal CancerRecruiting
Est. primary completion 2028-09-25 · NCT06252649 · CT.gov ↗
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December 2028 (1)
Phase 2Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid NeoplasmActive not recruiting
Est. primary completion 2028-12-31 · NCT05638295 · CT.gov ↗
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2029 (2)
June 2029 (1)
Phase 2Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8Not yet recruiting
Est. primary completion 2029-06-01 · NCT07543172 · CT.gov ↗
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September 2029 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-09 · NCT07563738 · CT.gov ↗
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2030 (3)
June 2030 (1)
Phase 2Colorectal Carcinoma, KRAS G12C Mutation, Unresectable Colorectal CancerNot yet recruiting
Est. primary completion 2030-06-30 · NCT07124884 · CT.gov ↗
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July 2030 (1)
Phase 2Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 …Recruiting
Est. primary completion 2030-07-01 · NCT05564377 · CT.gov ↗
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August 2030 (1)
Phase 1Pancreatic AdenocarcinomaRecruiting
Est. primary completion 2030-08-08 · NCT06892054 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (4)
Phase 2 (20)
Phase 1/2 (9)
Phase 1 (30)
Phase 4 (1)
Used as active comparator (1)