A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer

NCT05297890 | Active Not Recruiting Phase 2

• 1 other identifier: CS3011-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 31

Brief Summary

A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib Monotherapy in Crizotinib and Platinum-based Chemotherapy Treated Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)Subjects in China

Conditions

Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

Secondary Outcomes (12)

• Duration of response (DoR) as assessed by RECIST v1.1 per ICR assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

• ORR assessed by RECIST version 1.1 per investigator assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

• DoR assessed by RECIST version 1.1 per investigator assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

• Disease control rate (DCR) at 12 and 24 week as assessed by RECIST v1.1 per ICR assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

• Time to tumor response (TTR) as assessed by RECIST v1.1 per ICR assessment

  From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

Study Arms (1)

Lorlatinib

EXPERIMENTAL

Drug：Lorlatinib 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

Dosage Form: Lorlatinib tablet, Dosage: 25mg/tablet, Dosing Regimens: 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle

Lorlatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically or cytologically confirmed diagnosis of locally advanced or metastatic ROS1 gene arrangement positive NSCLC.
• Subject should have radiological disease progression while on treatment with crizotinib as the only prior ROS1 inhibitor.
• Participants must have been treated with platinum-based doublet chemotherapy for locally advanced/metastatic disease for at least 1 cycle and must have radiological disease progression on or after that. Participants who do not tolerate platinum-based doublet chemotherapy may be included provided they have been treated for at least 1 cycle.
• Prior treatment with small molecules or cytotoxic agents must have completed ≥5 half-lives prior to initiating study treatment; Prior treatment with antibodies must have completed at least 3 weeks prior to initiating study treatment.
• All Subjects must have at least 1 measurable target lesion (intracranial or extracranial) according to RECIST v1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1, or 2.
• Age ≥18 years.
• Subjects must have adequate organ function as assessed in the laboratory tests.
• Acute effects of prior anti-cancer treatment resolved to baseline severity or to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 except for AEs that in the investigator's judgment do not constitute a safety risk for the subject.
• Serum or urine pregnancy test (for females of childbearing potential) negative at screening.
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• Willing and able to comply with the study scheduled visits, treatment plans, laboratory tests, and other procedures.

You may not qualify if:

• More than 1 prior chemotherapy regimen prior to enrollment in the locally advanced/metastatic setting.
• Subject's cancer has a known primary driver alteration other than ROS1 gene rearrangement.
• Major surgery within 4 weeks prior to the first dose.
• Radiation therapy within 2 weeks prior to the first dose. Palliative radiation must have been completed at least 48 hours prior to the first dose. Stereotactic or partial brain irradiation must have completed at least 2 weeks prior to the first dose. Whole brain irradiation must have completed at least 4 weeks prior to the first dose.
• Spinal cord compression unless the subject has good pain control attained through therapy, and there is complete recovery of neurological function for the 4 weeks prior to the first dose.
• Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes.
• Known prior or suspected severe hypersensitivity to lorlatinib or any component in the formulation; known prior therapy with lorlatinib.
• Severe acute or chronic infections.
• Clinically significant cardiovascular disease (both arterial and venous) and non-vascular cardiac conditions (active or within 3 months prior to the first dose).
• Subject with predisposing characteristics for acute pancreatitis according to investigator judgment, including but not limited to uncontrolled hyperglycemia, current gallstone disease, in the last month prior to the first dose.
• History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis.
• Evidence of active malignancy within the last 3 years prior to the first dose.
• Concurrent use of any of the prohibited food or drugs required in protocol within 12 days prior to the first dose of administration of lorlatinib.
• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, would make the subject inappropriate for entry into this study.
• Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead
• Pfizer: collaborator

Study Sites (31)

Guangdong Provincial People's hospital

Guangzhou, Guangdong, 510080, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Chinese PLA Army Medical Center

Chongqing, China

Location

Fujian Cancer Hospital

Fuzhou, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

The first Affiliated hospital, Sun Yat-Sen University

Guangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Shandong Cancer Hospital&Institute

Jinan, China

Location

Yunnan Cancer Hospital

Kunming, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, China

Location

Shanxi Cancer hospital

Taiyuan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

The 1st Affiliated hospital of Wenzhou Medical University

Wenzhou, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Tangdu Hospital of The fourth Military Medical University Peoples Liberation Army of China

Xi'an, China

Location

Xiamen Humanity Hospital

Xiamen, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Interventions

lorlatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: May 27, 2022
• Primary Completion: December 26, 2023
• Study Completion: May 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (31)