New drug shows promise for rare lung cancer subtype

NCT ID NCT04919811

Disease control Sponsor: Nuvation Bio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a drug called taletrectinib in 217 people with advanced or metastatic ROS1-positive non-small cell lung cancer and other solid tumors. The main goal is to see how well the drug shrinks tumors and to check its safety. Participants take the drug by mouth daily, and researchers track tumor response and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: taletrectinib (a targeted cancer drug)
What this could lead to: If successful, this could provide a new treatment option for people with ROS1-positive lung cancer that has spread or cannot be removed by surgery.
What could go wrong: This is a mid-stage trial with no placebo group, so results may not confirm real-world benefit. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

217 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years (or ≥20 years as required by local regulations). 2. Histologically or cytologically confirmed diagnosis of locally advanced (including inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC (Cohorts 1-3, 5) or other solid tumors including NSCLC patients ineligible for other cohorts (Cohort 4). 3. Evidence of ROS1 fusion by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent diagnostic laboratories. The molecular assays (i.e., Reverse Transcription Polymerase Chain Reaction \[RT-PCR\], Next-generation Sequencing \[NGS\]) are highly recommended. 4. Sufficient tumor tissue is required for patients in Cohort 1 and for TKI-naïve patients in Cohort 5 in order to perform confirmatory ROS1 fusion testing at the designated central laboratories. For patients in Cohort 1 and for TKI-naïve patients in Cohort 5, an archival tumor tissue specimen should be available and collected prior to enrollment. If archival tumor tissue is unavailable, then a fresh biopsy must be performed. Tumor tissue for patients in other cohorts is highly recommended, and tumor tissue obtained after progression on the most recent prior ROS1 TKI therapy in these cohorts is preferred. Cytology samples (e.g., pleural effusion cell pellets) may be acceptable for patients in Cohorts 2-4, and patients in Cohort 5 that received prior treatment with TKI(s) having ROS1 activity. 5. Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, must be stable (either asymptomatic or previously treated and controlled are allowed: * Seizure prophylaxis is permitted with non-enzyme inducing anti-epileptic drugs (non-EIAEDs). * Corticosteroid treatment at a stable or decreasing dose within 7 days prior to the first dose of taletrectinib. * Whole brain radiation therapy (WBRT) must be completed at least 14 days and stereotactic radiotherapy, stereotactic radiosurgery, or gamma knife radiotherapy at least 7 days prior to enrollment; the patient must be clinically stable for 7 days according to investigator judgement prior to first dose of taletrectinib. 6. The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1 TKI(s): o Cohort 1: Patients with locally advanced or metastatic ROS1-positive NSCLC. Systemic chemotherapy naïve or pretreated with 1 prior line of chemotherapy but never treated with any ROS1 TKI. o Cohort 2: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with 1 approved ROS1 TKI (crizotinib or entrectinib) and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC. * Cohort 3: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with ≥2 TKIs with ROS1 activity and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC, patients with known ROS1 resistant mutations are preferred. * Cohort 4: Patients with other ROS1-positive solid tumors, or NSCLC patients ineligible for Cohorts 1-3. Prior treatment with ≤3 TKIs with ROS1 activity. The patient can be either chemotherapy naïve or has received ≤2 lines of systemic chemotherapy for locally advanced or metastatic solid tumors. * Cohort 5: Patients with locally advanced or metastatic ROS1-positive NSCLC. The patient can be either chemotherapy naïve or has received ≤2 lines of systemic chemotherapy line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC. ROS1-TKI-naïve or pretreated with TKI(s) having ROS1 activity. 7. At least 1 measurable disease per RECIST 1.1 as assessed by the investigator. 8. Eastern Cooperative Oncology Group Performance Status: 0 or 1. 9. Patient with a life expectancy ≥12 weeks based on the judgement of investigator. 10. Patients with adequate organ function meeting the following criteria: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper limit of normal (ULN) (or ≤5.0 × ULN, for patients with concurrent liver metastases) 2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy) 3. Absolute neutrophil count: ≥1,500/μL 4. Platelet count: ≥100,000/μL 5. Hemoglobin: ≥9.0 g/dL 6. Serum creatinine ≤1.5 × ULN and estimated creatinine clearance (CLcr) ≥45 mL/min as calculated using the method standard for the institution (e.g., Cockcroft - Gault Equation) 11. Males and/or females who meet any of the following criteria: a. For males (irrespective of surgical sterilization \[vasectomy\]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug or agree with complete abstinence. b. Females without menses for at least 1 year prior to screening or documented to be surgically sterilized. Women of childbearing potential (WOCBP) must agree to use two concurrent highly effective methods of contraception or agree with complete abstinence from sexual intercourse since the informed consent until 45 days after the last dose of investigational drug. Usage of hormonotherapy for contraception should be recorded as well. 12. For all females of childbearing potential, a negative pregnancy test must be obtained within 7 days before starting study treatment. Female patients of non childbearing potential must meet at least 1 of the following criteria: ○ Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. ○ Have undergone a documented hysterectomy and/or bilateral oophorectomy. ○ Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential. 13. The patient is willing and capable to give written informed consent. 14. The patient is willing and capable to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. 15. The patient is willing and capable to comply with study site's COVID-19 policies. Exclusion Criteria 1. Treatment with small molecule anticancer therapy including other investigational agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of the compound, whichever is shorter) prior to the first dose of taletrectinib; or treatment with monoclonal antibodies, including immune checkpoint inhibitors within 4 weeks before the first dose of taletrectinib. 2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks before the first dose of taletrectinib. Note: Placement of vascular access device is not considered major surgery. Other minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed. 3. Radiation outside the chest and brain \<7 days prior to C1D1. 4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. 5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not returned to baseline, by the first dose of taletrectinib except for AEs not constituting a safety risk to the patient based on the judgment of investigators. 6. Patients with untreated spinal cord compression caused by tumor and/or cancerous meningitis. 7. History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis (Excluding clinically insignificant or asymptomatic post radiation pneumonitis). 8. Any gastrointestinal disorders that may affect absorption of oral medications. 1\. 9. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. Note that the following are permitted: ○ Patients treated for hepatitis C (HCV) or HIV with no detectable viral load; for at least 1 month prior to the first dose of taletrectinib. Note: caution with drug drug interactions of concomitant anti HIV agents and CYP3A substrates. ○ Patients with known hepatitis B (HBV) infections: * With past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of hepatitis B surface antigen \[HBsAg\]); or * With inactive HBV carrier state (defined as HBsAg positive, with normal ALT, and HBV DNA \<2,000 IU/mL or \<10,000 copies/mL). Note: Please consider that, for patients in an inactive HBV carrier state or with a resolved HBV infection, there may be a risk of HBV reactivation, and anti HBV prophylaxis should be considered. 10\. Clinically significant cardiovascular diseases within 3 months prior to the first dose of taletrectinib: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack. 11\. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) \>470 milliseconds, or symptomatic bradycardia \<45 beats per minute; patient has family or medical history of long QT syndrome. 12\. Pregnancy or lactation/breastfeeding. 13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment. 14\. Administration of agents with potential QT interval prolonging effect within 14 days prior to first dose of study treatment and while on treatment. 15\. Patients with other severe medical or mental diseases in whom the risk is increased by participation to the study or treatment with study treatment in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

AOU Cagliari- P.O. Policlinico Universitario Duilio Casula

Monserrato, 09042, Italy
APHP- Hôpital Europeen Georges Pompidou (HEGP)

Paris, 75015, France
Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan
Asan Medical Center

Seoul, 05505, South Korea
Azienda Ospedaliera Universitaria- Università degli Studi della Campania

Naples, 80131, Italy
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States
CHU Grenoble Alpes- Hospital Michallon

La Tronche, 38700, France
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, France
CHU Rennes - Hospital Pontchaillou

Rennes, 35033, France
CHU de Poitiers Pole regional

Poitiers, 86000, France
Cancer Specialists of North Florida

Jacksonville, Florida, 92868, United States
Center for Cancer Research

Brick, New Jersey, 08724, United States
Centre Léon Bérard

Lyon 08, 69373, France
Centre d'Essais Précoces de Cancerologie de Marseille

Marseille, 13005, France
Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Clinica Mi Tres Torres

Barcelona, 08017, Spain
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy
Henan Cancer Hospital

Zhengzhou, China
Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain
Hospital Quironsalud Barcelona

Barcelona, 08023, Spain
Hospital Regional Universitario de Malaga

Málaga, 29010, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen Macarena

Seville, 41009, Spain
Humanitas Istituto Clinico Catanese, Misterbinanoco

Catania, 95045, Italy
Hunan Cancer Hospital

Changsha, China
ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat

Barcelona, 08908, Spain
IEO Istituto Europeo di Oncologia

Milan, 20141, Italy
Institut De Cancérologie De L'ouest

Saint-Herblain, 44805, France
Institut Gustave Roussy

Saint-Herblain, 44805, France
Institut Jean Godinot

Reims, 51726, France
Instituto Valenciano de Oncologia IVO

Valencia, 46009, Spain
Instytut Centrum Zdrowia Matki Polki

Lodz, Poland
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico

Bari, 70124, Italy
Keck Medicine of University of Southern California

Los Angeles, California, 90089, United States
Kindai University Hospital

Osaka, 589-8511, Japan
Korea University Guro Hospital

Seoul, 08308, South Korea
MD Anderson Cancer Center

Houston, Texas, 77030, United States
MICS Centrum Medyczne Toruńa

Torun, 87-100, Poland
Mayo Clinic

Rochester, Minnesota, 55902, United States
McGill University Health Centre Research Institute

Montreal, Quebec, Canada
Med-Polonia Sp. z o.o.

Poznan, 60-693, Poland
Memorial Cancer Institute at Memorial Hospital East

Hollywood, Florida, 33021, United States
Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida, 33028, United States
Moores Cancer Center at UC San Diego

La Jolla, California, 92037, United States
National Cancer Center Hospital

Tokyo, 104-0045, Japan
National Cancer Center Hospital East

Kashiwa, 104-0045, Japan
National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan
Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States
Ospedale San Raffaele

Milan, 20132, Italy
Princess Margaret Cancer Centre

Toronto, Ontario, Canada
Pusan National University Hospital

Busan, 49241, South Korea
Pusan National University Yangsan Hospital

Gyeongsang, 999007, South Korea
Renovatio Clinical

El Paso, Texas, 19915, United States
Renovatio Clinical

The Woodlands, Texas, 77380, United States
SCRI - Florida Cancer Specialists South

Fort Meyers, Florida, 33901, United States
SCRI - Hematology Oncology Clinic

Baton Rouge, Louisiana, 70809, United States
SCRI - Tennessee Oncology

Nashville, Tennessee, 37203, United States
Sendai Kousei Hospital

Miyagi, 980-0873, Japan
Shandong Cancer Hospital

Jinan, China
Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
Shizuoka Cancer Center

Shizuoka, 411-8777, Japan
Texas Oncology, P.A.

Dallas, Texas, 75246, United States
The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China
The Oncology Institute of Hope and Innovation

Glendale, California, 91204, United States
UCI Medical Center

Orange, California, 92868, United States
Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States
West China Hospital

Chengdu, China
Wuhan Union Hospital

Wuhan, China

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