Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or CytologyPhase 2NCT07874282
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
A Phase 2 study testing Telisotuzumab adizutecan plus RC148(ABBV-1480) in people with Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Efficacy of RC148 in Combination with Telisotuzumab adizutecan as First-line Treatment for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
- What is being tested?
- Telisotuzumab adizutecan plus RC148(ABBV-1480)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Feb 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agrees to participate in the study and provides signed informed consent
- Willing and able to comply with study and follow-up procedures
- Male or female, aged 18-80 years
- Expected survival≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histopathologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC not amenable to curative-intent therapy
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- No prior systemic anti-neoplastic therapy for advanced or metastatic non-squamous NSCLC
- At least one measurable non-cerebral lesion per RECIST v1.1
- Availability of c-Met expression, PD-L1 expression and driver gene test results including at minimum EGFR and ALK for enrollment
- Adequate cardiac, bone-marrow, hepatic, renal and coagulation function meeting relevant criteria
- Female study participants must be post-menopausal, surgically sterilized, or, if of child-bearing potential, have a negative serum pregnancy test within 7 days prior to the first dose, agree to use at least one medically-accepted contraceptive method during study treatment and for 12 months after the end of study treatment, and refrain from oocyte donation and breastfeeding during this period; male study participants must agree to use at least one medically-accepted contraceptive method during study treatment and for 12 months after the end of study treatment and refrain from sperm donation during this period
Who cannot join
- Histologically confirmed presence of any squamous NSCLC, small-cell carcinoma, neuroendocrine carcinoma, or sarcoma component
- Known positive driver gene or gene mutations with approved first-line treatment options
- Presence of active brain metastases
- Screening-period imaging shows obvious tumor necrosis or cavitation, with bleeding risk upon study entry as judged by the investigator
- Received thoracic radiotherapy >30 Gy within 6 months prior to randomization; palliative local therapy for non-target lesions within 2 weeks prior to randomization; non-specific immunomodulatory therapy within 2 weeks prior to the first dose of study drug; or traditional Chinese herbal/proprietary medicine with anti-neoplastic indications within 1 week prior to randomization
- Prior immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune-cell therapy, or any other therapies targeting tumor immune mechanisms
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- Prior systemic anti-neoplastic therapies other than chemotherapy and PD-1/PD-L1 antibodies
- Systemic treatment with corticosteroids or other immunosuppressive medications within 2 weeks prior to randomization
- Administration of any live or live-attenuated vaccine within 4 weeks prior to randomization, or planned administration of any live or live-attenuated vaccine during the study
- Participation in another clinical trial within 4 weeks prior to randomization
- Major surgery, interventional therapy, or severe trauma within 4 weeks prior to randomization, or planned major surgery during the study period; core-needle biopsy or other minor surgery within 7 days prior to the first dose
- History of severe coagulation disorders; or subjects receiving anticoagulant therapy, excluding prophylactic-dose anticoagulants such as low-molecular-weight heparin
- Toxicities from prior anti-neoplastic therapy not recovered to Grade 0-1 as defined by CTCAE v6.0; except for alopecia, pigmentation, expected irrecoverable endocrinopathies from prior immunotherapy that are stably controlled with medication, and other conditions assessed by the investigator not interfering with study drug treatment
- For subjects previously exposed to PD-1/PD-L1 inhibitors: prior occurrence of immune-related adverse events (irAEs) Grade 3 or higher due to immunotherapy, irAEs leading to permanent treatment discontinuation, Grade 2 immune-related cardiac toxicity, or any-grade neurological or ocular irAEs; prior adverse events requiring immunosuppressive agents other than corticosteroids, or recurrent adverse events during prior immunotherapy requiring re-initiation of systemic corticosteroid therapy
- Presence of severe acute or chronic infection
- Hemoptysis, active gastrointestinal bleeding, peptic ulcer, epistaxis, or other bleeding events requiring intervention within 4 weeks prior to randomization; or severe esophagogastric varices, vasculitis, vascular ulcer, aneurysm, or vascular dissection judged by the investigator to carry a high bleeding risk
- Severe arterial/venous thromboembolic events or cerebrovascular accident within 6 months prior to the first dose
- Active or clinically significant cardiac disease
- History of interstitial lung disease or pulmonary inflammation requiring systemic steroid therapy; or chest-CT at screening showing any evidence of active ILD/pulmonary inflammation, idiopathic pulmonary fibrosis, organizing pneumonia, treatment-induced pneumonitis, idiopathic pneumonia, radiation pneumonitis, severe impaired pulmonary function, or acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to randomization
- History of gastrointestinal perforation and/or fistula, or gastrointestinal obstruction within 6 months prior to randomization
- Presence of systemic diseases that are not stably controlled as judged by the investigator
- Active autoimmune disease, or prior history of autoimmune disease with potential for recurrence
- Subjects with a history of other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Known hypersensitivity or delayed-type allergic reaction to any components of the study drug or analogous medicinal products
- Clinically symptomatic third-space effusion or third-space effusion requiring intervention
- Other malignancy diagnosed within 3 years prior to initiation of study drug administration
- Poor compliance; subjects expected to be unable to cooperate with completion of trial procedures
- Any other past or present disease, abnormal physical finding, or laboratory abnormality, in the investigator's opinion, rendering the subject unsuitable for study drug administration, likely to confound interpretation of study results, or placing the subject at high-risk
- Local or systemic disease not caused by malignancy, or diseases/symptoms secondary to the tumor, that may result in substantial medical risk and/or uncertainty in survival-time assessment, such as manifestations of cachexia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of Telisotuzumab Adizutecan in Combination With RC148 as First-Line Therapy for Non-Squamous Non-Small-Cell Lung Cancer
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Efficacy of RC148 in Combination with Telisotuzumab adizutecan as First-line Treatment for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
- Being tested
- Telisotuzumab adizutecan plus RC148(ABBV-1480)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab adizutecan plus RC148(ABBV-1480)Drug
Dose1
Telisotuzumab adizutecan plus RC148(ABBV-1480)Drug
Dose2
| Study group | Role | What they receive |
|---|---|---|
| Dose1:Telisotuzumab adizutecan plus RC148(ABBV-1480) | Experimental | Not described Receives: Drug: Telisotuzumab adizutecan plus RC148(ABBV-1480) |
| Dose2:Telisotuzumab adizutecan plus RC148(ABBV-1480) | Experimental | Not described Receives: Drug: Telisotuzumab adizutecan plus RC148(ABBV-1480) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate assessed by the investigators according to RECIST v1.1
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or CytologyStudies of the same condition, open and under way.
- More trials run by RemeGen 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874282
- Sponsor's protocol ID
- RC148-A201
- Status last verified
- Nov 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study to Evaluate the Efficacy and Safety of Telisotuzumab Adizutecan in Combination With RC148 as First-Line Therapy for Non-Squamous Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07874282
- Acronym / sponsor ID
- RC148-A201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Oct 2026 (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.
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Efficacy of RC148 in Combination with Telisotuzumab adizutecan as First-line Treatment for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose1:Telisotuzumab adizutecan plus RC148(ABBV-1480) | Experimental | Drug: Telisotuzumab adizutecan plus RC148(ABBV-1480) |
| Dose2:Telisotuzumab adizutecan plus RC148(ABBV-1480) | Experimental | Drug: Telisotuzumab adizutecan plus RC148(ABBV-1480) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily agrees to participate in the study and provides signed informed consent
- Willing and able to comply with study and follow-up procedures
- Male or female, aged 18-80 years
- Expected survival≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (29 listed)
- Histologically confirmed presence of any squamous NSCLC, small-cell carcinoma, neuroendocrine carcinoma, or sarcoma component
- Known positive driver gene or gene mutations with approved first-line treatment options
- Presence of active brain metastases
- Screening-period imaging shows obvious tumor necrosis or cavitation, with bleeding risk upon study entry as judged by the investigator
- Received thoracic radiotherapy >30 Gy within 6 months prior to randomization; palliative local therapy for non-target lesions within 2 weeks prior to randomization; non-specific immunomodulatory therapy within 2 weeks prior to the first dose of study drug; or traditional Chinese herbal/proprietary medicine with anti-neoplastic indications within 1 week prior to randomization
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 |
|---|---|---|
| Telisotuzumab adizutecan plus RC148(ABBV-1480)Dose1 | Drug | Dose1:Telisotuzumab adizutecan plus RC148(ABBV-1480) |
| Telisotuzumab adizutecan plus RC148(ABBV-1480)Dose2 | Drug | Dose2:Telisotuzumab adizutecan plus RC148(ABBV-1480) |
Primary outcome
Objective Response Rate assessed by the investigators according to RECIST v1.1
Time frame: 24 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 6 Nov 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telisotuzumab adizutecan plus RC148(ABBV-1480) in people with Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology, run by RemeGen Co., Ltd. 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 11 inclusion and 29 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: opening soon, as of the sponsor's last update on 6 Nov 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?
Contact Jiang Guo (010-65384976, jiang.guo@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate assessed by the investigators according to RECIST v1.1 (time frame: 24 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 6 Nov 2026.