Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Phase IB/II, Open Label, Multicenter Study of Selumetinib Administered Orally in Combination With Gefitinib in Patients With EGFR-mutated Non-small Cell Lung Cancer Who Have Developed Acquired Resistance of EGFR Inhibitor Treatment
This is an open-label, non-randomized, multicenter phase Ib/II study, which is composed of a phase Ib dose escalation part and a phase II dose expansion part. Patients will receive selumetinib in combination with gefitinib 250mg daily. This study will enroll EGFR-mutated NSCLC patients who have developed acquired resistance to EGFR TKI treatment.
he primary objective of the dose escalation part is to determine the MTD and/or RP2D of
selumetinib in combination with gefinitib. Once MTD and/or RP2D has been determined in the
phase Ib dose escalation phase, study drug selumetinib with combination of 250mg QD dose of
gefitinib will be further evaluated in a phase II dose expansion phase of the study. The
purpose of the dose expansion phase is to evaluate the efficacy of selumetinib in combination
of gefitinib and to further characterize the safety, and tolerability of the combination.
20 patients will be required in the phase II period. In the expansion phase, 10 patients with
T790M and 10 patients without T790M will be enrolled. It is assumed that 20% response rate is
the target of clinical interest. If the true response rate is 20%, the probability of
observing no responses in a random sample of 10 patients is 0.107. The false negative rate
for detecting a true 20% response rate in each cohort is approximately 10%. Each cohort will
be enrolled 10 patients to evaluate the efficacy; therefore 20 patients will be enrolled in
dose expansion part. Patients treated at the MTD and/or RP2D during the phase Ib will be
considered as part of the required number of patients in the phase II. Patients at the MTD or
RP2D cannot contribute to the 20 patients require for phase II part.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT03667820 -
Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
|
Phase 2 | |
| Recruiting |
NCT01994057 -
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
|
||
| Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT01193959 -
Pemetrexed in Advanced Non-small Cell Lung Cancer
|
||
| Recruiting |
NCT01028729 -
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
| Completed |
NCT00770588 -
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
| Active, not recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
| Completed |
NCT01951157 -
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
|
Phase 2 | |
| Recruiting |
NCT01964157 -
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement
|
Phase 2 | |
| Active, not recruiting |
NCT04026412 -
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
|
Phase 3 | |
| Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03260491 -
HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT05207423 -
A Chart Review Study of Adults With Advanced NSCLC
|
||
| Terminated |
NCT02608528 -
Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
|
||
| Completed |
NCT01463423 -
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
|
N/A | |
| Recruiting |
NCT02927340 -
A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions
|
Phase 2 | |
| Recruiting |
NCT02521051 -
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02403193 -
Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
|
Phase 1 |