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NCT05948462: NSCLC
Phase II Study of Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib
Phase 2 trial testing Lorlatinib in Lung Cancer. Withdrawn.
1 March 2025
Quick facts
| Lead sponsor | SCRI Development Innovations, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 November 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 September 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Lorlatinib (lorlatinib) — full drug profile →
- Cisplatin or Carboplatin
- Pemetrexed — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Sponsor
SCRI Development Innovations, LLC — full company profile →
Who can join
18 and older, any sex, with Lung Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of adverse and serious adverse events of lorlatinib in combination with standard of care platinum-based chemotherapy and pemetrexed as assessed by CTCAE v5.0.
Time frame: From Cycle 1 Day 1 to 30 days after treatment discontinuation, up to approximately 1 year. Each cycle is 3 weeks.
Sponsor's own description
This clinical trial is an open-label, single arm study evaluating the safest dose of lorlatinib in combination with standard of care chemotherapy in participants with metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC who progressed on prior therapy of lorlatinib alone. The main goals of this study are to: * Evaluate the safety and tolerability of lorlatinib in combination with standard of care chemotherapy. * Evaluate how well the combination of lorlatinib and standard of care chemotherapy works to treat metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC. * Evaluate the pharmacokinetics (PK) of lorlatinib when given in combination with standard of care chemotherapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05948462
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lorlatinib
Trials testing the same drug.
- NCT07415005 — Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT06678555 — A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out. · active not recruiting
- NCT06487078 — Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World C · NA · recruiting
- NCT06282874 — Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases · Phase 4 · active not recruiting
Other recruiting trials for Lung Cancer
Currently open trials in the same condition.
- NCT07295821 — Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study · Phase 2 · recruiting
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- NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
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- NCT07146568 — Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hos · NA · recruiting
Other SCRI Development Innovations, LLC trials
Trials by the same sponsor.
- NCT04699630 — A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer · Phase 2 · completed
- NCT04402138 — Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma · Phase 2 · completed
- NCT04200365 — A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) · Phase 2 · terminated
- NCT04209725 — A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia · Phase 2 · terminated
- NCT04361058 — Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05948462 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SCRI Development Innovations, LLC
- Last refreshed: 11 December 2023
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/NCT05948462.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing