Overview
Sponsor-declared trial summary
Histologically confirmed locally advanced or metastatic solid tumor (Strata A, B, D): Specification for Stratum C: Only patients with NSCLC adenocarcinomas, (squamous or adenosquamous not permitted) who are scheduled to receive platin + pembrolizumab + pemetrexed standard treatment (only for Stratum C) Specification for Stratum E: Including only metastatic or irresectable locally advanced urothelial carcinomas (only for Stratum E)
Key facts
- Sponsor
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Aug 2017 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516026-56-00
- EudraCT number
- 2016-002309-20
- ClinicalTrials.gov
- NCT03252938
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Histologically confirmed locally advanced or metastatic solid tumor (Strata A, B, D): Specification for Stratum C: Only patients with NSCLC adenocarcinomas, (squamous or adenosquamous not permitted) who are scheduled to receive platin + pembrolizumab + pemetrexed standard treatment (only for Stratum C) Specification for Stratum E: Including only metastatic or irresectable locally advanced urothelial carcinomas (only for Stratum E)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 20.0 | LLT | 10068069 | Peritoneal carcinomatosis | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Sponsor organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Address
- Steinbacher Hohl 2-26, Praunheim Praunheim
- City
- Frankfurt Am Main
- Postcode
- 60488
- Country
- Germany
Scientific contact point
- Organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Contact name
- Johanna Riedel
Public contact point
- Organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Contact name
- Johanna Riedel
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 110 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2017-08-17 | 2018-09-08 | 2026-01-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Germany | Acceptable 2024-10-15
|
2024-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-25 | Germany | Acceptable 2025-09-26
|
2025-09-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-15 | Germany | Acceptable 2025-09-26
|
2026-04-15 |