Advanced or Metastatic ROS1-Positive Non-Small Cell Lung CancerPhase 2NCT05297890
A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer
A Phase 2 study testing Lorlatinib in people with Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer, run by CStone Pharmaceuticals at 31 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer
- What is being tested?
- Lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 31 sitesChina
- Study dates
- 27 May 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Pregnant female subjects; breastfeeding female subjects.
- Any use of traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of investigational product.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Beijing Cancer Hospital
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
The First Hospital of Jilin University
Changchun
Hunan Cancer Hospital
Changsha
Sichuan Cancer Hospital & Institute
Chengdu
West China Hospital of Sichuan University
Chengdu
Chinese PLA Army Medical Center
Chongqing
Fujian Cancer Hospital
Fuzhou
Guangdong Provincial People's hospital
Guangzhou, Guangdong, 510080
Sun Yat-sen University Cancer Center
Guangzhou
The first Affiliated hospital, Sun Yat-Sen University
Guangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
The First Affiliated Hospital of Anhui Medical University
Hefei
Shandong Cancer Hospital&Institute
Jinan
Yunnan Cancer Hospital
Kunming
The First Affiliated Hospital of Nanchang University
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Province Hospital
Nanjing
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Pulmonary Hospital
Shanghai
Liaoning Cancer Hospital and Institute
Shenyang
Shanxi Cancer hospital
Taiyuan
Tianjin Medical University Cancer Institute & Hospital
Tianjin
The 1st Affiliated hospital of Wenzhou Medical University
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Tangdu Hospital of The fourth Military Medical University Peoples Liberation Army of China
Xi'an
Xiamen Humanity Hospital
Xiamen
Henan Cancer Hospital
Zhengzhou
Henan Provincial People's Hospital
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: 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 Subjects in China
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
- Being tested
- Lorlatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
Dosage Form: Lorlatinib tablet, Dosage: 25mg/tablet, Dosing Regimens: 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| Lorlatinib | Experimental | Drug：Lorlatinib 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Progression-free survival (PFS) as assessed by RECIST v1.1 per ICR assessment
Measured: 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
Intracranial Objective Response (IC-OR) as assessed by RECIST v1.1 per ICR assessment
Measured: 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
Duration of intracranial response (IC-DoR) as assessed by RECIST v1.1 per ICR assessment
Measured: 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
Overall survival (OS)
Measured: 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
To evaluate the safety and tolerability of lorlatinib treatment
Measured: 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
Lorlatinib concentration will be used for population PK analysis
Measured: 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
patient-reported outcomes (PROs) as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 (self-assessment questionnaires)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start27 May 2022
- Primary completion26 Dec 2023
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic ROS1-Positive Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297890
- Sponsor's protocol ID
- CS3011-201
- Status last verified
- May 2026
- First submitted
- 17 Mar 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Subjects in China
- ClinicalTrials.gov ID
- NCT05297890
- Acronym / sponsor ID
- CS3011-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 27 May 2022 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorlatinib | Experimental | Drug: LorlatinibDrug：Lorlatinib 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibDosage Form: Lorlatinib tablet, Dosage: 25mg/tablet, Dosing Regimens: 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle | Drug | Lorlatinib |
Primary outcome
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment
Time frame: 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
12 secondary outcomes
Duration of response (DoR) as assessed by RECIST v1.1 per ICR assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Progression-free survival (PFS) as assessed by RECIST v1.1 per ICR assessment
Time frame: 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
Intracranial Objective Response (IC-OR) as assessed by RECIST v1.1 per ICR assessment
Time frame: 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
Duration of intracranial response (IC-DoR) as assessed by RECIST v1.1 per ICR assessment
Time frame: 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
Overall survival (OS)
Time frame: 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
To evaluate the safety and tolerability of lorlatinib treatment
Time frame: 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
Lorlatinib concentration will be used for population PK analysis
Time frame: 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
patient-reported outcomes (PROs) as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 (self-assessment questionnaires)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lorlatinib in people with Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer, run by CStone Pharmaceuticals at 31 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.