Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma

Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04173338

Enrollment

Registered

2019-11-21

Start date

2020-01-23

Completion date

2022-03-28

Last updated

2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma, Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma

Brief summary

This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.

Interventions

DRUGCabozantinib

start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.

DRUGPemetrexed

Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Locally advanced NSCLC, urothelial cancer or malignant mesothelioma. * 18 years or older. * At least one prior chemotherapy before entering in this trial. * Not pregnant or breastfeeding.

Exclusion criteria

* Prior treatment with cabozantinib. * Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study). * History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.

Design outcomes

Primary

Measure	Time frame	Description
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed	4 weeks or 28 days assessment.	Dose-limiting toxicity of grade 3 or higher using CTCAE 5

Secondary

Measure	Time frame	Description
Assess objective response rate (RR)	To be measured through study completion; an average of 1 year.	RR measured by Tumor response evaluation with RECIST
Progression-free survival (PFS)	To be measured through study completion; an average of 1 year.	PFS measured from the time of study treatment to the date of progression.
Overall survival (OS).	OS measured through study completion, and an average of 1 year	Measured from the time of start of treatment to time of death or time of last assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026