Clinical trials: KRAS Mutant Non-Small Cell Lung Cancer
Lung Cancer (NSCLC), KRAS G12C Lung Cancer
Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)
This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib…
- Trial name
- GIVEN (NCT07472478)
- Testing
- Garsorasib, Ivonescimab Combined With Chemotherapy, Surgery
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Guangdong Provincial People's Hospital
Non-small Cell Lung Cancer
Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)
This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.
- Trial name
- NCT03095612
- Testing
- Selinexor, Docetaxel
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of Texas Southwestern Medical Center
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- MOONRAY-01 (NCT06586515)
- Testing
- LY3962673, Cetuximab, Gemcitabine
- Where
- 52 sites in United States, Canada and 7 more
- Volunteers
- 630 people
- Sponsor
- Eli Lilly and Company
Cancer, Malignancy
A Study of ASN007 in Patients With Advanced Solid Tumors
The study is divided into two parts. The first part of the study will test various doses of ASN007 to find out the highest safe dose to test in five specific groups.
- Conditions
- Cancer, Malignancy, Neoplasia, Neoplasm
- Trial name
- NCT03415126
- Testing
- ASN007: ascending doses, ASN007 RD
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Asana BioSciences
Neoplasms, Carcinoma, Non-Small-Cell Lung
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03948763
- Testing
- V941, Pembrolizumab
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Colorectal Cancer
Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus…
- Trial name
- M13DAP (NCT02039336)
- Testing
- Dacomitinib, PD-0325901, Docetaxel
- Where
- 3 sites in Netherlands
- Volunteers
- 35 people
- Sponsor
- The Netherlands Cancer Institute
KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors…
- Conditions
- KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC), Other KRAS-mutant Solid Tumors
- Trial name
- NCT07458347
- Testing
- KST-6051, Gemcitabine/nab-paclitaxel, Cetuximab
- Where
- 9 sites in United States
- Volunteers
- 545 people
- Sponsor
- Kestrel Therapeutics, Inc.
Non-Small Cell Lung Cancer, Melanoma
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.
- Trial name
- NCT02974725
- Testing
- LXH254, LTT462, Trametinib
- Where
- 32 sites in United States, Australia and 9 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC.
- Trial name
- SUNRAY-01 (NCT06119581)
- Testing
- LY3537982, Pembrolizumab, Cisplatin
- Where
- 416 sites in United States, Australia and 27 more
- Volunteers
- 1,264 people
- Sponsor
- Eli Lilly and Company
Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor
- Trial name
- NCT05462717
- Testing
- RMC-6291
- Where
- 64 sites in United States, Australia and 11 more
- Volunteers
- 222 people
- Sponsor
- Revolution Medicines, Inc.
Colorectal Neoplasms, Gastrointestinal Neoplasms
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and…
- Conditions
- Colorectal Neoplasms, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
- Trial name
- M14AFS (NCT02450656)
- Testing
- Afatinib, Selumetinib, Docetaxel
- Where
- 2 sites in Netherlands
- Volunteers
- 320 people
- Sponsor
- The Netherlands Cancer Institute
KRAS Gene Mutation
Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.
- Trial name
- NCT03808558
- Testing
- TVB-2640
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- David E Gerber
Non Small Cell Lung Cancer
Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients
This is a Phase I exploratory study. The study is divided into two parts (A/B).In part A, the primary endpoint is the determination of the recommended phase 2 dose (RP2D).
- Trial name
- NCT04967079
- Testing
- Trametinib, Anlotinib
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Shanghai Chest Hospital
Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT06128551
- Testing
- Elironrasib, Daraxonrasib
- Where
- 56 sites in United States, France and 5 more
- Volunteers
- 534 people
- Sponsor
- Revolution Medicines, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer)
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer
This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy…
- Trial name
- NCT07554859
- Testing
- ArmA:GFH375, Arm B:GFH375, Arm C:GFH375
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
NSCLC (Non-small Cell Lung Cancer)
Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC
This is a multicenter, randomized, open-label, phase 3 clinical trial designed to evaluate the efficacy and safety of JMKX001899 compared to docetaxel in patients with previously treated, KRAS G12C-mutant advanced or metastatic…
- Trial name
- NCT07242274
- Testing
- JMKX001899, Docetaxel
- Where
- China
- Volunteers
- 472 people
- Sponsor
- Jemincare
Non-small Cell Lung Cancer
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage…
- Trial name
- KANDLELIT-013 (NCT07431827)
- Testing
- Calderasib, MK-3475A
- Where
- 117 sites in Argentina, Australia and 17 more
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
- Conditions
- Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation
- Trial name
- NCT04965818
- Testing
- Futibatinib and Binimetinib
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Taiho Oncology, Inc.
Non-Small Cell Lung Cancer
Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced NSCLC
This is an open-label, dose-escalation Phase I study to evaluate the safety and tolerability of RX001 monotherapy in patients with advanced KRAS mutant NSCLC.
- Trial name
- NCT06934590
- Testing
- RX001
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- GeneCraft Inc.
Advanced Solid Tumors
A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors
The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced KRAS G12C-mutant non-small cell…
- Trial name
- NCT06024174
- Testing
- BMS-986466, Adagrasib, Cetuximab
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb