Non-Small Cell Lung CancerPhase 3NCT06569420

Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC

A Phase 3 study testing Drug: Foritinib Succinate and Drug: Crizotinib in people with Non-Small Cell Lung Cancer and ALK-positive, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, ALK-positive, SAF-189s
What is being tested?: Drug: Foritinib Succinate and Drug: Crizotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 1 siteChina
Study dates: 31 Dec 2021to 31 Dec 2027
Phase: Phase 3
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

Sufficiently understand the study and are willing to sign the informed consent form (ICF);
Male or female patients ≥ 18；
Histologically or cytologically confirmed diagnosis of local advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC;
ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory;
Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment; Lesions that have received radiation therapy cannot be considered as target lesions unless there is confirmed progression of the lesion after radiation therapy;
Participants with no prior systemic treatment for local advanced (Stage IIIB/IIIC not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC;

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Eastern cooperative oncology group performance status (ECOG PS) of 0-2;
Life expectancy of at least 12 weeks;
Adequate organ and bone marrow function as documented by:Hematologic function: absolute neutrophil count (ANC) ≥1.5 × 10^9/L; hemoglobin≥ 90 g/L; Platelet count ≥ 100 × 109/L;Serum total bilirubin ≤ 1.5 × ULN (if the patient has Gilbert's syndrome, ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN);Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patient with liver metastases);Creatinine clearance (CrCL) ≥ 50 mL/min (calculated by Cockcroft-Gault equation)；Baseline QTc ≤470 ms corrected by Fridericia fomula;Baseline LVEF≥50%;
For all females of childbearing potential (FCBP), a negative serum pregnancy test result must be obtained within 7 days prior to starting study treatment, and agree to use a highly effective method of contraception, during the treatment period and for 3 months following the last dose of study drug.For men whose partners are fertile women, agreement to remain abstinent or use a condom plus an additional contraceptive method during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. This protocol defines a FCBP as a sexually mature woman who:1）has not undergone a hysterectomy or bilateral oophorectomy；2）has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out child-bearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Who cannot join

Has had prior anti-cancer treatment with biological drugs, or other investigational agents within 28 days; or received chemotherapy, TKI or targeted therapies within 14 days prior to enrollment; or based on the last administration within 5 half-life of the drug (whichever is shorter);
Patients with central nervous system (CNS) metastases requiring: 1）clinical local intervention such as surgical excision, radiotherapy or other therapies (known brain metastasis or other CNS metastasis that is either asymptomatic or symptomatic but requiring no local interventions may qualify for the study per the investigator); 2）patients requiring systemic treatment with corticosteroids and >10 mg/day prednisone or equivalent; 3）requiring antiepileptic drug sustained treatment;
Spinal cord meatstasis with potential risk of or symptomic spinal cord compression;
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 5.0) Grade 2 or higher toxicities due to any prior therapy (e.g., chemotherapy, surgery or radiotherapy) (excluding alopecia)
Patient has uncontrolled diabetes and intervented by insulin (patient with fasting blood glucose levels <9.8 mmol/L under stable oral hypoglycemic medications allowed to be enrolled);
Has a history of acute pancreatitis within 1 year before enrollment, ;

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Patients have history of interstitial lung disease, drug-induced interstitial lung disease or induced by radiation therapy and requring hormone therapy, or still receiving medication or other clinical intervention, or currently having active pulmonary interstitial lesions;
The patients had uncontrollable amounts of pleural effusion, ascites, and pericardial effusion.
Patients with inability to swallow or with active digestive system disease or underwent major GI surgery, which remarkably affect oral administration or absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea and vomiting, diarrhea, malabsorption syndrome, and small bowel resection);
History of hypersensitivity to any of the additives in the SAF-189s and drug formulation;
History of hypersensitivity to any of the additives in the crizotinib and drug formulation;
Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen-positive and hepatitis B virus DNA over 2000 IU/mL, positive for hepatitis C virus (HCV) antibody test; confirmed human immunodeficiency virus (HIV) infection, and those who are unwilling to undergo HIV testing; hepatitis B carriers are allowed to be enrolled;
Patients have other malignant tumor history in 3 years or with other malignant tumors simultaneously (excluding curatively treated in situ carcinoma of cervix cancer, non-melanoma skin basal cell carcinoma, thyroid carcinoma in situ, and any cured tumor which is considered to have no impact in progression-free survival (PFS) or overall survival (OS) for the current NSCLC);
Patients with cardiac function impairment or clinically significant heart diseases, including congestive heart-failure New York Heart Association (NYHA) III or above, arrhythmias (including but not limited to complete left bundle branch Atrioventricular block complete and atrioventricular block second degree), conduction abnormality requiring medication, severe coronary artery disease, heart valve disease or myocardiopathy or uncontrolled hypertension;
Patients who received major surgery within 3 weeks before enrollment or have not adequately recovered from prior surgery. Major surgery is defined as Grade 3 or 4 surgery per Management Measures for Clinical Application of Medical Technology implemented on May 1st, 2009 in China;
Patients who have been received one of the following treatments: 1）strongly inhibits or induces of CYP3A4, repaglinide (cytochrome [CYP]2C8 sensitive substrate) and drugs metabolized via CYP3A4 enzyme within 1 week before enrollment; 2）medicines which are known to cause QT prolongation or torsade de pointes;3）coumarin anticoagulants within 1 week before enrollment (low molecular weight heparin is permitted);4）illegal drugs;
Pregnant or lactating: any subjects who experience pregnancy during the trial need to withdraw from the study.
Any other clinically significant disease or condition, or acute or chronic medical conditions (such as uncontrolled diabetes), or mental condition or abnormal lab test, that investigator assesses that maybe increase the risk of participating or affect the interpretation of research reslults.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Pulmonary Hospital
Shanghai

Other trials in China

About this study

Official title: A Randomized, Multicenter, Phase III Open-label Study: Efficacy and Safety of Comparing SAF-189s With Crizotinib in First-line Anaplastic Lymphoma Kinase-positive Advanced and Metastatic NSCLC

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either SAF-189s (160 milligrams [mg] once daily [QD]) or crizotinib (250 mg BID) orally, respectively.

Conditions: Non-Small Cell Lung Cancer, ALK-positive, SAF-189s
Being tested: Drug: Foritinib Succinate, Drug: Crizotinib
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug: Foritinib SuccinateOther
Also called SAF-189s
SAF-189s: 160 mg QD, 21 days a cycle
Drug: CrizotinibOther
Crizotinib: 250 mg BID, 21 days a cycle

Study groups in NCT06569420
Study group	Role	What they receive
Foritinib Succinate	Experimental	Foritinib Succinate capsules will be administered orally at a dose of 160 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death. Other Names: SAF-189s Receives: Other: Drug: Foritinib Succinate
Control: Crizotinib	Active comparator	Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death. Receives: Other: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS) by IRC
as determined by IRC based on RECIST 1.1 criteria.
Measured: up to 36 months
Overall survival (OS)
Time in months from date of randomization to death due to any cause
Measured: up to 60 months
Progression-free survival (PFS) by INV
as determined by INV based on RECIST 1.1 criteria.
Measured: up to 36 months
Objective Response Rate (ORR) by IRC and INV
Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by Investigators and IRC According to RECIST V1.1 Criteria
Measured: up to 36 months
Duration of response (DOR) by IRC and INV
Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first.
Measured: up to 36 months
to evaluate the C-ORR in patient with CNS metastases.
Measured: up to 36 months
to assess the C-TTR in patient who have as CNS objective response
Measured: up to 36 months
to assess the C-DOR in patient who have as CNS objective response.
Measured: up to 36 months
to assess the C-TTP in patient who have as CNS objective response.
Measured: up to 36 months
The time to CNS progression in ITT by IRC.
To evaluate the time to CNS progression in ITT by IRC.
Measured: up to 36 months
Incidence of adverse events.
Measured: up to 36 months
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a better level in functional scales/items and Global health status, or worse level in symptom scales/items.
Measured: up to 36 months
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire LC13 Score
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a worse level in symptom scales/items, such as in cough, short breath, chest pain, and other symptoms associated with lung cancer.
Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202131 Dec 2027

First posted26 Aug 2024
Study start31 Dec 2021
Primary completion31 Jul 2025 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06569420
Sponsor's protocol ID: SAF-189-III101
Status last verified: Jul 2024
First submitted: 2 Aug 2024
Last updated: 26 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Phase III Open-label Study: Efficacy and Safety of Comparing SAF-189s With Crizotinib in First-line Anaplastic Lymphoma Kinase-positive Advanced and Metastatic NSCLC
ClinicalTrials.gov ID: NCT06569420
Acronym / sponsor ID: SAF-189-III101
Conditions: Non-Small Cell Lung Cancer, ALK-positive, SAF-189s
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 275 participants (actual)
Lead sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
Study start: 31 Dec 2021 (actual)
Primary completion: 31 Jul 2025 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 26 Aug 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Foritinib Succinate	Experimental	Other: Drug: Foritinib SuccinateForitinib Succinate capsules will be administered orally at a dose of 160 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death. Other Names: SAF-189s
Control: Crizotinib	Active comparator	Other: Drug: CrizotinibCrizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Sufficiently understand the study and are willing to sign the informed consent form (ICF);
Male or female patients ≥ 18；
Histologically or cytologically confirmed diagnosis of local advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC;
ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory;
Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment; Lesions that have received radiation therapy cannot be considered as target lesions unless there is confirmed progression of the lesion after radiation therapy;

Key exclusion criteria (18 listed)

Has had prior anti-cancer treatment with biological drugs, or other investigational agents within 28 days; or received chemotherapy, TKI or targeted therapies within 14 days prior to enrollment; or based on the last administration within 5 half-life of the drug (whichever is shorter);
Patients with central nervous system (CNS) metastases requiring: 1）clinical local intervention such as surgical excision, radiotherapy or other therapies (known brain metastasis or other CNS metastasis that is either asymptomatic or symptomatic but requiring no local interventions may qualify for the study per the investigator); 2）patients requiring systemic treatment with corticosteroids and >10 mg/day prednisone or equivalent; 3）requiring antiepileptic drug sustained treatment;
Spinal cord meatstasis with potential risk of or symptomic spinal cord compression;
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 5.0) Grade 2 or higher toxicities due to any prior therapy (e.g., chemotherapy, surgery or radiotherapy) (excluding alopecia)
Patient has uncontrolled diabetes and intervented by insulin (patient with fasting blood glucose levels <9.8 mmol/L under stable oral hypoglycemic medications allowed to be enrolled);

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
Drug: Foritinib SuccinateAlso: SAF-189sSAF-189s: 160 mg QD, 21 days a cycle	Other	Foritinib Succinate
Drug: CrizotinibCrizotinib: 250 mg BID, 21 days a cycle	Other	Control: Crizotinib

Primary outcome

Progression-free survival (PFS) by IRC
Time frame: up to 36 months
as determined by IRC based on RECIST 1.1 criteria.
Overall survival (OS)
Time frame: up to 60 months
Time in months from date of randomization to death due to any cause
Progression-free survival (PFS) by INV
Time frame: up to 36 months
as determined by INV based on RECIST 1.1 criteria.
Objective Response Rate (ORR) by IRC and INV
Time frame: up to 36 months
Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by Investigators and IRC According to RECIST V1.1 Criteria
Duration of response (DOR) by IRC and INV
Time frame: up to 36 months
Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first.
to evaluate the C-ORR in patient with CNS metastases.
Time frame: up to 36 months
to assess the C-TTR in patient who have as CNS objective response
Time frame: up to 36 months
to assess the C-DOR in patient who have as CNS objective response.
Time frame: up to 36 months
to assess the C-TTP in patient who have as CNS objective response.
Time frame: up to 36 months
The time to CNS progression in ITT by IRC.
Time frame: up to 36 months
To evaluate the time to CNS progression in ITT by IRC.
Incidence of adverse events.
Time frame: up to 36 months
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
Time frame: up to 36 months
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a better level in functional scales/items and Global health status, or worse level in symptom scales/items.
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire LC13 Score
Time frame: up to 36 months
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a worse level in symptom scales/items, such as in cough, short breath, chest pain, and other symptoms associated with lung cancer.

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 26 Aug 2024.
Individual participant dataSharing planned: No

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 18 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-free survival (PFS) by IRC (time frame: up to 36 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569420.

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 26 Aug 2024.