Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
218
Countries
4
Sites
17
Non-Squamous Non-Small Cell Lung Cancer
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib. Phase …
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib.
Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of efficacy measured by PFS based on BICR assessment.
Secondary objectives 6
- Phase 2: To further evaluate the efficacy of telisotuzumab adizutecan in combination with osimertinib as measured by PFS, DoR, DCR, and OS.
- Phase 2: To characterize the PK and immunogenicity of telisotuzumab adizutecan in combination with osimertinib.
- Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of OS
- Phase 3: To further evaluate the efficacy of telisotuzumab adizutecan in combination with osimertinib as measured by ORR, DoR, and DCR compared with standard of care.
- Phase 3: To evaluate the impact of telisotuzumab adizutecan in combination with osimertinib on patient-reported lung cancer symptoms as measured by the EORTC QLQ-LC13.
- Phase 3: To evaluate the impact of telisotuzumab adizutecan in combination with osimertinib on patient-reported physical functioning and GHS/QoL as measured by the relevant domains of the EORTC QLQ-C30.
Conditions and MedDRA coding
Non-Squamous Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.
- All participants must consent to provide recently obtained FFPE tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met IHC testing and study stratification. c-Met IHC results are required prior to randomization.
- Participants must have at least one non-irradiated measurable disease per RECIST version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
- Any toxicities from prior systemic anti-cancer therapy must have resolved to CTCAE Grade 1 or baseline level (except for alopecia [any grade] or Grade ≤ 2 peripheral neuropathy).
- Participants should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
Exclusion criteria 4
- History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- History of any malignancy other than disease under study except for a. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator. b. Successfully treated nonmelanoma skin cancer. c. Localized carcinoma in situ of the cervix. d. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.
- Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1
- Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
Secondary endpoints 11
- Phase 2: PFS based on BICR assessment per RECIST version 1.1.
- Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.
- Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.
- Phase 2: Overall Survival
- Phase 3: Overall Survival
- Phase 3: OR based on BICR assessment per RECIST version 1.1.
- Phase 3: DoR based on BICR assessment per RECIST version 1.1.
- Phase 3: DC based on BICR assessment per RECIST version 1.1.
- Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30
- Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13.
- Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11535908 · Product
- Active substance
- Telisotuzumab Adizutecan
- Substance synonyms
- Telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide, ABBV-400, DC-1951796
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176340 · Substance
- Active substance
- Osimertinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176340 · Substance
- Active substance
- Osimertinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Clario ORL-000001148
|
Philadelphia, United States | Other |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| Iqvia Biotech Limited ORG-100008726
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Wayland, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
Locations
4 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 9 | 4 |
| Italy | Authorised, recruiting | 18 | 5 |
| Portugal | Ongoing, recruiting | 8 | 3 |
| Spain | Ongoing, recruiting | 15 | 5 |
| Rest of world
Canada, Korea, Republic of, Australia, Japan, Singapore, China, United States, Israel, Taiwan
|
— | 168 | — |
Investigational sites
UZ Leuven
Pulmonology, Herestraat 49, 3000, Leuven
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Algemeen Ziekenhuis Delta
Oncology, Deltalaan 1, 8800, Roeselare
Centre hospitalier universitaire de Liege
Pneumology, Avenue De L'Hopital 1, 4000, Liege
Ospedale San Raffaele S.r.l.
UOC Oncologia Medica, Via Olgettina 60, 20132, Milan
Universita' Campus Bio-medico Di Roma
Medical Oncology, Via Alvaro Del Portillo 200, 00128, Rome
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologica Medica 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU Medical Oncology, Regione Gonzole 10, 10043, Orbassano
Hospital Santa Maria Della Misericordia
S.C. Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Unidade Local De Saude De Santo Antonio E.P.E.
oncology, Largo Professor Abel Salazar, 4050-011, Porto
Hospital CUF Porto S.A.
oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
CCAB Centro Clinico Academico Braga Associacao
oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Fundacion Instituto Valenciano De Oncologia
Oncología, Calle Professor Beltran Baguena 8, 46009, Valencia
Institut Catala D'oncologia
Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
oncología médica, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Oncología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Oncología, Avenida De Cordoba Sn, 28041, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-09-30 | 2025-11-19 | |||
| Italy | 2025-11-11 | ||||
| Portugal | 2025-09-18 | 2026-04-02 | |||
| Spain | 2025-10-17 | 2026-04-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 49 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m25287-protocol_Redacted - Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M25-287 BE Recruitment and ICF Procedures _Public | 1 |
| Recruitment arrangements (for publication) | K1 M25-287 IT EU CTR Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1 M25-287 PT EU CTR Recruitment and ICF Procedures_ Public | 1 |
| Recruitment arrangements (for publication) | K1_M25-287 ES EU CTR Recruitment and ICF Procedures_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Addendum ICF - Dutch - Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Addendum ICF - English - Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Addendum ICF - French - Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Escalation - English -Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Escalation - French -Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Escalation -Dutch -Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Optimization-Expansion - Dutch -Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Optimization-Expansion - English - Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Main ICF - Dose Optimization-Expansion - French -Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Dose Escalation - Dutch - Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Dose Escalation - English - public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Dose Escalation - French- public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Dose Optimization-Expansion - Dutch - public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Dose Optimization-Expansion- English - Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Optional ICF - Optimization-Expansion- French - public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Dose Escalation - Dutch - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Dose Escalation - English - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Dose Escalation - French - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Dose Optimization-Expansion - Dutch - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Optimization-Expansion - English - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 BE Preg Part ICF - Optimization-Expansion - French - Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-287 IT Dose Escalation Combined ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-287 IT Dose Expansion Combined ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-287 IT Pregnat Authorization for data release form_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-287 PT Addendum ICF Imagiologic Disease Progression _Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-287 PT Combined Main and Optional Escalation ICF Public | 6.0 |
| Subject information and informed consent form (for publication) | L1 M25-287 PT Combined Main and Optional optimization expansion ICF_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1 M25-287 PT Pregnancy ICF Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M25-287 ES Continued Treatment following disease progression ICF_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-287 ES Main ICF - Dose escalation_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-287 ES Main ICF - Dose expansion-Dose optimization_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-287 ES Optional ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-287 ES Pregnant Partner ICF_Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc_osimertinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_spc-carboplatin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_spc-cisplatin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_spc-pemetrexed | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-DE-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-EN-EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-ES-ES | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-FR-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-IT-IT | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-NL-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25287-euctr-synopsis-PT-PT | 1.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-29 | Portugal | Acceptable 2025-08-25
|
2025-08-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-12 | Acceptable | 2025-11-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-19 | Acceptable | 2025-10-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-26 | Acceptable | 2025-11-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Portugal | Acceptable 2026-03-09
|
2026-03-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-27 | Portugal | Acceptable | 2026-04-14 |