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TNO155 / Advanced Solid Tumors Harboring the KRAS G12C Mutation / Cetuximab · Phase 1/2 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record describing a planned rollover study, not a published results report. The study aims to provide continued access to opnurasib for participants who benefited from prior Novartis-sponsored trials and to monitor safety over approximately 3 years. No efficacy or safety outcomes are reported in this registry entry.
Phase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation; age from 18 Years; to 100 Years. Intervention: Group 1: opnurasib single agent; Group 2: opnurasib + TNO155; Group 3: opnurasib + trametinib; Group 4: opnurasib + cetuximab; Group 5: opnurasib + tislelizumab. n = 40. 14 sites across 9 countries.
This is a clinical trial registry record describing a planned rollover study, not a published results report. The study aims to provide continued access to opnurasib for participants who benefited from prior Novartis-sponsored trials and to monitor safety over approximately 3 years. No efficacy or safety outcomes are reported in this registry entry.
Safety and efficacy data are not provided in this registry entry.
This rollover study does not provide clinical evidence on efficacy or safety; it is an access pathway for participants already benefiting from opnurasib in completed or active studies. Clinicians should await published results from the parent trials to inform practice decisions.
This is a rollover/access study with no reported efficacy results; it documents continued treatment in benefiting participants and ongoing safety monitoring in Phase 1/2 populations.
As stated by the source record.
Quoted from the source exactly as published.
This rollover study does not provide clinical evidence on efficacy or safety; it is an access pathway for participants already benefiting from opnurasib in completed or active studies. Clinicians should await published results from the parent trials to inform practice decisions.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07468071). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation. Interventions: DRUG: Opnurasib; DRUG: TNO155; DRUG: trametinib; BIOLOGICAL: cetuximab; BIOLOGICAL: tislelizumab. Primary outcome measures: Number of participants receiving opnurasib as single agent or in combination with other study treatments , Assessed up to approximately 3 years; Duration of exposure to study treatment , Assessed up to approximately 3 years. Brief summary: The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.