Who is sponsoring NCT03114319?

NCT03114319 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03114319?

Interventions in NCT03114319: TNO155, TNO155 in combination with EGF816 (nazartinib).

What condition does NCT03114319 study?

NCT03114319 studies Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal Squamous Cell Cancer (SCC), Head/Neck SCC, Melanoma, Advanced Gastrointestinal Stromal Tumors (GIST), Advanced NRAS/BRAFT wt Cutaneous Melanoma.

Is NCT03114319 still recruiting?

NCT03114319 is currently terminated. Last updated 16 April 2026.

Last reviewed 2026-04-16 · How we verify

NCT03114319

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors

Terminated Phase 1 Last updated 16 April 2026

What this trial tests

Phase 1 trial testing TNO155 in Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) in 227 participants. Terminated before completion.

Timeline

26 May 2017

Primary endpoint
4 July 2025

4 July 2025

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	227
Start date	26 May 2017
Primary completion	4 July 2025
Estimated completion	4 July 2025
Sites	18 locations across Italy, Japan, Netherlands, Taiwan, South Korea, Canada, Singapore, United States

Drugs / interventions tested

TNO155 — full drug profile →
TNO155 in combination with EGF816 (nazartinib) — full drug profile →

Conditions studied

Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) — all drugs for Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) →
KRAS G12-mutant NSCLC — all drugs for KRAS G12-mutant NSCLC →
Esophageal Squamous Cell Cancer (SCC) — all drugs for Esophageal Squamous Cell Cancer (SCC) →
Head/Neck SCC — all drugs for Head/Neck SCC →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 99, any sex, with Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) or KRAS G12-mutant NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this first in human (FIH) trial was to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

RAS-targeted therapies: is the undruggable drugged?
Moore AR, Rosenberg SC, McCormick F, Malek S. · · 2020 · cited 832× · PMID 32528145 · DOI 10.1038/s41573-020-0068-6
KRAS mutation: from undruggable to druggable in cancer.
Huang L, Guo Z, Wang F, Fu L. · · 2021 · cited 728× · PMID 34776511 · DOI 10.1038/s41392-021-00780-4
The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Inhibition of Inflammatory Signaling in Tet2 Mutant Preleukemic Cells Mitigates Stress-Induced Abnormalities and Clonal Hematopoiesis.
Cai Z, Kotzin JJ, Ramdas B, Chen S, et al · · 2018 · cited 329× · PMID 30526882 · DOI 10.1016/j.stem.2018.10.013
Expanding the Reach of Precision Oncology by Drugging All KRAS Mutants.
Hofmann MH, Gerlach D, Misale S, Petronczki M, et al · · 2022 · cited 247× · PMID 35046095 · DOI 10.1158/2159-8290.cd-21-1331
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0

Verify or expand the search:

Other trials of TNO155

Trials testing the same drug.

NCT07468071 — Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agen · Phase 1, PHASE2 · not yet recruiting
NCT05541159 — Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Hea · Phase 1 · withdrawn
NCT05490030 — Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy · Phase 1 · withdrawn
NCT04699188 — Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation · Phase 1, PHASE2 · active not recruiting
NCT04294160 — A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer · Phase 1 · terminated

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03114319 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03114319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing