Data updated: May 26, 2026
LUMAKRAS (sotorasib)
Genetically Validated
Trial Activity: Growth 20 active trials
First-in-Class Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval Fast Track
Oncology
Approved 2021-05-28
LUMAKRAS is indicated for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer; KRAS G12C-mutated metastatic colorectal cancer.
Source: FDA Label • Amgen
How LUMAKRAS Works
Sotorasib is an inhibitor of KRAS G12C, a mutant-oncogenic form of the KRAS protein. The drug forms an irreversible covalent bond with the protein, locking it in an inactive state and preventing the downstream signaling that drives tumor cell growth. This mechanism specifically targets the mutant protein without affecting wild-type KRAS. In colorectal cancer, sotorasib is used with an EGFR antagonist to overcome resistance mechanisms associated with epidermal growth factor receptor activation.
Development Insights
Amgen conducting 14 trials (37%)
57 indications explored (Broad Platform)
→ non-small cell lung cancer (7 trials)
→ stage iv lung cancer ajcc v8 (4 trials)
→ healthy participants (4 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-05-28
- Patent Cliff
- 2040
- Revenue
- $92M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
LUMAKRAS Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
21 FDA actions from 2021 to 2025 · 1 indication expansions
What LUMAKRAS Treats
2 indicationsLUMAKRAS is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
- KRAS G12C-mutated metastatic colorectal cancer
Source: FDA Label
LUMAKRAS Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
LUMAKRAS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LUMAKRAS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LUMAKRAS treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
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Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07012031 | NCI-2025-03809 NCI-2025-03809, MCC 23419 | Ph 1, Ph 2 | recruiting | Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation |
| NCT05638295 | NCI-2022-09876 NCI-2022-09876, EAY191-E5 | Ph 2 | active not recruiting | Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT07563738 TEADCO | 3134003 | Ph 1, Ph 2 | recruiting | A 2-part Phase 1/2 Open-label Trial on ODM-212 |
| NCT05920356 | 20190341 2022-501863-41-00 | Ph 3 | recruiting | A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) |
| NCT05398094 MERIT-lung | GECP 20/10_MERIT-lung 2021-004576-34 | Ph 2 | recruiting | Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy |
| NCT05198934 CodeBreak300 | 20190172 2024-511187-81-00 | Ph 3 | completed | Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation |
| NCT06252649 CodeBreaK 301 | 20210081 | Ph 3 | recruiting | Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation |
| NCT07543172 | I-4697425 NCI-2026-02049, I-4697425 | Ph 2 | not yet recruiting | CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer |
| NCT06497556 Krascendo 1 | BO45217 2024-510908-37-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer |
| NCT06333951 | 20230167 | Ph 1 | recruiting | Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). |
| NCT07172919 | 20250089 2025-522355-26, U1111-1322-4422 | Ph 2 | recruiting | A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation |
| NCT04892017 | DCC-3116-01-001 2022-501474-19-00 | Ph 1 | terminated | Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors |
| NCT06249282 | 23477 NCI-2023-11093, 23477 | Ph 1 | recruiting | Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer |
| NCT06582771 | 24-049 | Ph 2 | recruiting | A Study of Sotorasib in People With Non-Small Cell Lung Cancer |
| NCT06804824 | VVD-159642-01 | Ph 1 | recruiting | A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors |
| NCT03600883 | 20170543 | Ph 1, Ph 2 | active not recruiting | A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) |
| NCT05845450 | UNICORN | Ph 2 | recruiting | Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) |
| NCT06333678 | 22-321 | Ph 2 | completed | A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) |
| NCT05054725 results posted | RMC-4630-03 | Ph 2 | completed | Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies |
| NCT05815173 | 22-00959 | Ph 1 | recruiting | Ladarixin With Sotorasib in Advanced NSCLC |
| NCT04625647 | S1900E NCI-2020-08103, S1900E | Ph 2 | active not recruiting | Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) |
| NCT04185883 | 20190135 2023-506794-35 | Ph 1 | active not recruiting | Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) |
| NCT04933695 CodeBreaK201 | 20190288 2021-002638-18 | Ph 2 | completed | A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment |
| NCT06807619 | 24-111 | Ph 1 | recruiting | A Study of Sotorasib in People With Brain Tumors |
| NCT05374538 results posted | VIC-1911-01 | Ph 1 | terminated | VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer |
| NCT04720976 | JAB-3312-1003 | Ph 1, Ph 2 | completed | JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors |
| NCT05480865 Argonaut | NAV-1003 | Ph 1 | terminated | SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation |
| NCT06068153 AMBER | ETOP 24-22 | Ph 2 | withdrawn | AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC |
| NCT04092673 Zotatifin | eFT226-0002 | Ph 1, Ph 2 | recruiting | Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies |
| NCT04887064 results posted | 20200362 | Ph 1 | completed | Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment |
| NCT06061523 | 20220098 | Ph 1 | withdrawn | A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants |
| NCT05815186 | 22-00959-2 | Ph 2 | withdrawn | Ladarixin With Sotorasib in Advanced NSCLC - Phase II |
| NCT05497557 results posted | 20220024 | Ph 1 | completed | A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers |
| NCT05327491 results posted | 20210088 | Ph 1 | completed | A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets |
| NCT05048784 results posted | 20210093 | Ph 1 | completed | A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants |
| NCT05045638 results posted | 20200426 | Ph 1 | completed | Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants |
| NCT04959981 HERKULES-2 | ERAS-007-02 | Ph 1 | completed | A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC |
| NCT05251038 | HCRN GI21-499 | Ph 1, Ph 2 | withdrawn | Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUMAKRAS FDA Label Details
Indications & Usage
FDA Label (PDF)LUMAKRAS is indicated for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer; KRAS G12C-mutated metastatic colorectal cancer.
View full patent landscape →
6 OB patents · 4 families ·
235 international docs across 40 countries
LUMAKRAS Patents & Exclusivity
Latest Patent: Sep 2040
Exclusivity: Jan 2032
Patents (6 active)
US11426404
Expires Sep 15, 2040
US11236091
Expires May 20, 2040
US12398133
Expires May 20, 2040
US11827635
Expires May 20, 2040
US12280056
Expires Nov 18, 2039
US10519146
Expires May 21, 2038
Exclusivity
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE*
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE*
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE-352
Until May 2028
ODE-507
Until Jan 2032
I-962
Until Jan 2028
NCE
Until May 2026
ODE*
Until May 2028
ODE-507
Until Jan 2032
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for LUMAKRAS
Revenue Insights
- • Q4-2025: $92M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 90 active patents
Trial Analysis
- • 38 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment