Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
47
Countries
5
Sites
17
Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
The primary objective of this rollover study is to provide continued access to opnurasib, administered as monotherapy or in combination, for participants who continue to derive clinical benefit from parent protocols.
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG, OMS ID: ORG-100003908
External identifiers
- EU CT number
- 2025-523537-26-00
- WHO UTN
- U1111-1330-1100
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Others, Safety
The primary objective of this rollover study is to provide continued access to opnurasib, administered as monotherapy or in combination, for participants who continue to derive clinical benefit from parent protocols.
Secondary objectives 1
- To collect safety data for opnurasib as single agent or in combination with other study treatments
Conditions and MedDRA coding
Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-003278-PIP01-22
- Plan to share IPD
- Yes
- IPD plan description
- Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-510082-10-00 | KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer. | Novartis Pharma AG |
| 2023-508073-87-00 | A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation | Novartis Pharma AG |
| 2024-511708-18-00 | KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation. | Novartis Pharma AG |
| 2023-506716-41-00 | KontRASt-03: A Phase Ib/II, multicenter, open-label platform study of JDQ443 with select combinations in patients with advanced solid tumors harboring the KRAS G12C mutation | Novartis Pharma AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Signed informed consent must be obtained prior to participation in the study.
- Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment.
- Participant has received at least 6 cycles of opnurasib in a parent study
- Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator
- Participant has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
- Participant is willing and able to comply with the scheduled visits and treatment plans.
Exclusion criteria 3
- Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study
- Participant is not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol
- Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of participants receiving opnurasib as single agent or in combination with other study treatments and duration of exposure
Secondary endpoints 1
- Safety and tolerability: • Frequency and severity/grade of adverse events (AEs) • Dose interruptions, reductions, and discontinuations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10717130 · Product
- Active substance
- 1-6-4M-4-5-CHLORO-6-METHYL-1H -INDAZOL-4-YL-5-METHYL-3-1-METHYL-1H -INDAZOL-5-YL-1H -PYRAZOL-1-YL-2-AZASPIRO33HEPTAN-2-YLPROP-2-EN-1-ONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10708991 · Product
- Active substance
- Batoprotafib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD14000768 · Product
- Active substance
- Tislelizumab
- Substance synonyms
- BGB-A317, JHL-2108
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Not Authorised
- ATC code
- L01FF09 — -
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Creapharm Clinical Supplies ORG-100020131
|
Reims, France | Other |
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 3 | 2 |
| Denmark | Authorised, recruitment pending | 4 | 1 |
| France | Authorised, recruitment pending | 7 | 5 |
| Italy | Authorised, recruitment pending | 6 | 4 |
| Spain | Authorised, recruitment pending | 11 | 5 |
| Rest of world
Canada, Malaysia, Japan, Singapore, China, Korea, Republic of
|
— | 16 | — |
Investigational sites
Vitaz
4201: Medical Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
UZ Leuven
4200: Digestive Oncology, Herestraat 49, 3000, Leuven
Rigshospitalet
8000: Clinical Research Unit Department of Cancer Treatment, 5072, Blegdamsvej 9, 2100, Copenhagen Oe
Centre De Cancerologue Du Grand Montpellier
4003: Medical Oncology , 25 Rue De Clementville, 34070, Montpellier
Institut Gustave Roussy
4001: Medical Oncology , 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
4004: Medical Oncology , Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Leon Berard
4000: Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
4002: Medical Oncology , 59 Boulevard Pinel, 69500, Bron
ASST Grande Ospedale Metropolitano Niguarda
4703: S.C.Oncologia Medica FALCK, Piazza Dell'ospedale Maggiore 3, 20162, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
4701: U.O.C. Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
4702: U.O.C. Oncologia Medica, Via Guglielmo Lippi Francesconi 556, 55100, Lucca
Istituto Nazionale Dei Tumori
4700: S.C. Oncologia Medica 1 Dipartimento di Onco-Ematologia, Via Giacomo Venezian 1, 20133, Milan
Hospital Universitari Vall D Hebron
5100: Servicio Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
5102: Servicio Oncología, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
5103: Servicio Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Navarra
5101: Servicio Oncología, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Virgen De La Victoria
5104: Servicio Oncología, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2025-523537-26-00_1_English_Red | 01 |
| Protocol (for publication) | D1_Protocol_2025-523537-26-00_1_English_Red | 01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BE_English_NonRed | 27Jan2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed | V1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 06Nov2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_French_NonRed | V00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_Dutch_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_English_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DK_Danish_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_IT_Italian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_BE_Dutch_NonRed | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_BE_English_NonRed | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_ES_Spanish_NonRed | 01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_FR_French_NonRed | V01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_IT_Italian_NonRed | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_Dutch_Red | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_English_Red | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | 01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | V01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_French_NonRed | 00 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_BE_English_Red | 21Jan2026 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | 06Nov2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Local SmPC_1_Cetuximab_BE_Dutch_NonRed | 28Jan26 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Local SmPC_1_Cetuximab_FR_French_NonRed | 16JAN2026 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Local SmPC_1_Cetuximab_IT_Italian_NonRed | 16Jan2026 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Cetuximab_English_NonRed | 6Jan26 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Tevimbra_English_NonRed | 10Nov2025 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_Dutch_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_English_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_French_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_German_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_Italian_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-523537-26-00_1_Spanish_NonRed | 00 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-18 | Belgium | Acceptable with conditions 2026-06-08
|
2026-06-08 |