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Non Small Cell Lung CancerPhase 2NCT04395677

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

A Phase 2 study testing AB-106 in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. 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
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Trial summary

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of AB-106 monotherapy in the treatment of advanced NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
AB-106
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteChina
Study dates
7 Jul 2020to Jun 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

  • Patients must meet all of the following criteria to be eligible for enrollment into the study:
  • ≥ 18 years of age
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • Positivity of ROS1 fusion is determined by the local qualified laboratories by using the FISH, RT-PCR or NGS assay, and the subject must provide archival tumor tissue sample for the confirmation by a sponsor-designated central laboratory
  • The subject is either TKI treatment naïve(Cohort A)， or has disease progression following the treatment of crizotinib （Cohort B）
  • The patient with brain metastases is either asymptomatic, or neurologically stable for at least 2 weeks prior to study entry
Show all 17Show fewer
  • Prior therapies (including chemotherapies [less than 3 lines of regimen], radiotherapy [except for palliative], or surgery) should be completed at least 2 weeks prior to study entry. The palliative radiotherapy (≤10 times) should be completed within 48 hours prior to study entry. Any acute toxic effect must be resolved to CTCAE Grade ≤1 except for alopecia
  • At least one measurable target tumor lesion (as accessed by RECIST v1.1) that has not been irradiated
  • ECOG Performance Status: 0 or 1
  • Patient with a life expectancy ≥ 3 months based on the judgement of investigators
  • Adequate organ functions defined by the following criteria：
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 x ULN; or ≤5 x ULN， if there is liver metastases involvement；
  • Total serum bilirubin ≤1.5 x ULN；
  • Absolute neutrophil count（ANC） ≥1500/µL；
  • Platelet count≥100,000/µL；
  • Hemoglobin≥8.0 g/dL；
  • Serum creatinine ≤2 x ULN. 11. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of the pertinent aspect of the study 12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures 13. Male and female patients of childbearing potential must agree to sue effective methods of contraception throughout the study and for 90 days after the last dose of study medication.

Who cannot join

  • Patient presenting with any of the following criteria will not be included in the study：
  • Current participation in other therapeutic investigational studies
  • Previous participation in the treatment or clinical trials of other ROS1-TKIs (except for crizotinib)
  • Previous participation in the treatment and clinical trials of ALK or NTRK fusion gene targeted therapies.
  • Spinal cord compression unless the patient demonstrates good pain control and stabilization or recovery of neurological function, carcinomatous meningitis or leptomeningeal disease
  • Patients with interstitial fibrosis or interstitial lung disease
Show all 18Show fewer
  • Any one of the following currently or in the previous 3 months: myocardial infarction, severe/unstable angina, coronary/ peripheral artery bypass graft, congestive heart failure or cerebrovascular accident including transient ischemic attack
  • Ongoing cardiac dysrhythmias of NCI CTCAE (v5.0) Grade≥2, uncontrolled atrial fibrillation of any grade, or QTc interval>470 microsec
  • Pregnancy or breastfeeding
  • Current use of food or drugs that are known strong CYP3A inhibitors, including (but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit or grapefruit juice.
  • Current use of drugs that are known strong CYP3A4 inducers, including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St John's Wort
  • Current use of drugs that are known CYP3A4 substrates with narrow therapeutic indices, including (but not limited to) dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine.
  • Current use of drugs that are known to induce QTc prolongation
  • Systematic treatment with anti-cancer therapy, including any Traditional Chinese Medicine (TCM)with anti-tumor effect indicated in the prescription information.
  • Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, and presumed cured prostate cancer) within the last 3 years
  • Clinically active viral disease with positivity of serum HIV, HBV, HCV, RPR testing
  • Difficult to swallow which may significantly impact drug absorption
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation in the judgement of investigator and sponsor

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of AB-106 monotherapy in the treatment of advanced NSCLC.

Read the detailed description

This is a Phase II, multicenter, single-arm, open label study of AB-106 in the Chinese patients with advanced NSCLC harboring ROS1 fusion gene.The study will be divided into two stages. First stage (Stage I) is to determine the clinical optimal dose of AB-106, which will be evaluated at two dose levels (400 mg QD and 600mg QD), and the safety, tolerability and pharmacokinetics of AB-106 will be evaluated at the same time; Second stage (Stage II) is to evaluate the efficacy and safety of AB-106 at the clinical optimal dose determined from Stage I. It is expected that 6 patients with advanced NSCLC harboring ROS1 fusion will be enrolled in the first stage. About 167 patients with ROS1 fusion will be enrolled in the second stage and divided into two treatment cohorts (Cohort A \& Cohort B). It is planned to enroll about 106 ROS1-TKI treatment naïve patients in Cohort A and about 67 crizotinib pre-treated patients in Cohort B. AB-106 will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator. The frequency of tumor assessments is once every 2 treatment cycles through Cycle 9, then every 3 treatment cycles through Cycle 27 and every 4 treatment cycles thereafter.

Being tested
AB-106
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.

  • AB-106Drug

    Also called DS-6051b

    Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients

    Stage 2: 600mg QD

Study groups in NCT04395677
Study groupRoleWhat they receive
AB-106 （DS-6051b）ExperimentalSingle-arm trial whereby all consented, enrolled, eligible patients receive AB-106
Receives: Drug: AB-106

What is being measured

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

  1. Best overall response (BOR) by IRC

    Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) according to RECIST 1.1

    Measured: 6 months

Secondary outcomes (14)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 25 months

  2. Rate of ECG QT Interval prolongation patients in all patients

    After the medicine, the number of patients with ECG QT Interval and the rate of patients with clinical significant

    Measured: 25 months

  3. Maximum Plasma Concentration [Cmax]

    The Cmax of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)

    Measured: Day 1 to Cycle1Day15

  4. Area under the curve from time zero to τ (dose interval τ is 24 h in this study) [AUCτ]

    The AUCτ of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)

    Measured: Day 1 to Cycle1Day15

  5. Average plasma concentration at steady state over dosing interval [Cav]

    The Cav of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)

    Measured: Day 1 to Cycle1Day15

  6. Trough plasma concentration [Ctrough]

    The Cthrough of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)

    Measured: Day 1 to Cycle1Day15

  7. Time to reach maximum plasma concentration [Tmax]

    The Tmax of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)

    Measured: Day 1 to Cycle1Day15

  8. Duration of Response(DOR)

    Duration of Response(DOR) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1

    Measured: 25 months

  9. Time to Response(TTR)

    Time to Response(TTR) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1

    Measured: 6 months

  10. Time to Progress(TTP)

    Time to Progress(TTP) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1

    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: 25 months

  11. Progression free Survival(PFS)

    Progression free Survival(PFS) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1

    Measured: 25 months

  12. Intracranial best overall response (IBOR)

    Intracranial Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) and Investigator according to RANO for intracranial lesion

    Measured: 25 months

  13. Duration of intracranial response (IDOR)

    Duration of intracranial response (IDOR) based on independent radiology review by Independent Review Committee(IRC) and Investigator according to RANO for intracranial lesion

    Measured: 25 months

  14. Overall Survival(OS)

    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: 51 months

Timeline

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

  1. First posted20 May 2020
  2. Study start7 Jul 2020
  3. Primary completion7 Jun 2024
  4. Study completionJun 2027 (estimated)

Resources

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
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395677
Sponsor's protocol ID
AB-106-C203
Status last verified
Feb 2026
First submitted
12 May 2020
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li W, Zhang Y, Fan H, Yu Q, Ran F, Chen W, Zhou C. Long-Term Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From the Phase II TRUST-I Study. J Clin Oncol. 2026 Jun 20;44(18):1670-1675. doi: 10.1200/JCO-26-00434. Epub 2026 Apr 21.

    PubMed 42013573

  • Perol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, Nagasaka M, Felip E, Xiong A, Zhang Y, Fan H, Wang X, Li S, Lai RK, Ran F, Zhang X, Chen W, Bazhenova L, Zhou C. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025 Jun;43(16):1920-1929. doi: 10.1200/JCO-25-00275. Epub 2025 Apr 3.

    PubMed 40179330

  • Li W, Xiong A, Yang N, Fan H, Yu Q, Zhao Y, Wang Y, Meng X, Wu J, Wang Z, Liu Y, Wang X, Qin X, Lu K, Zhuang W, Ren Y, Zhang X, Yan B, Lovly CM, Zhou C. Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study. J Clin Oncol. 2024 Aug 1;42(22):2660-2670. doi: 10.1200/JCO.24.00731. Epub 2024 Jun 1.

    PubMed 38822758

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AB-106 in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. at 1 site 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 17 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 6 Feb 2026. 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 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?

Best overall response (BOR) by IRC (time frame: 6 months). 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 NCT04395677, which also lists 3 linked publications.

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 6 Feb 2026.

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