Relapsed or Advanced Non-small Cell Lung CancerPhase 1/2NCT05503888
Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing Almonertinib combined with SHR-1701 and Almonertinib in people with Relapsed or Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Advanced Non-small Cell Lung Cancer
- What is being tested?
- Almonertinib combined with SHR-1701 and Almonertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Jul 2027
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily joined the study and signed informed consent
- Age 18~75 years old, both male and female
- Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
- At least one measurable lesion based on RECIST v1.1 criteria
- ECOG PS score: 0-1
- Have a life expectancy of at least 3 months
- Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating
Who cannot join
- Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
- Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
- Suffering from other malignant tumors in the past 3 years or at the same time
- Presence of any active or known autoimmune disease
- Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)
- Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
Show all 14Show fewer
- Have clinical symptoms or diseases of the heart that are not well controlled
- Patients with hypertension who are not well controlled by antihypertensive medication
- Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)
- Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).
- Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present
- Have active pulmonary tuberculosis.
- Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
- Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study of Almonertinib Combined With SHR-1701 or Other Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation
To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC
- Being tested
- Almonertinib combined with SHR-1701, Almonertinib
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almonertinib combined with SHR-1701Drug
Phase Ⅰb/Phase Ⅱ：
SHR-1701: injection, intravenous infusion
Almonertinib: tablets, oral
AlmonertinibDrug
Phase Ⅱ:
Almonertinib: tablets, oral
| Study group | Role | What they receive |
|---|---|---|
| Almonertinib combined with SHR-1701 | Experimental | Not described Receives: Drug: Almonertinib combined with SHR-1701 |
| Almonertinib | Placebo comparator | Not described Receives: Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity （Phase Ib）
Measured: 21 days after the first dose
The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib）
Measured: from the time when all informed subjects signed the informed consent to the end of the safety follow-up period
PFS rate at 12 months
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 12 months after the first medication for the last subject
Secondary outcomes (8)
Adverse Events and Serious Adverse Events
Measured: up to 3 years
Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial
Measured: up to 3 years
ORR
Measured: up to 3 years
DCR
Disease Control Rate, determined using RECIST v1.1 criteria
Measured: up to 3 years
DoR
Duration of Response, determined using RECIST v1.1 criteria
Measured: up to 3 years
DepOR
Depth of tumor remission, determined using RECIST v1.1 criteria
Measured: up to 3 years
PFS
Progression-Free-Survival, determined using RECIST v1.1 criteria
Measured: up to 3 years
OS
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a multicenter, open-label, dose-exploring, and efficacy expansion phase Ib/II study. The first phase explored two doses of SHR-1701 plus fixed dose of almonertinib to confirm RP2D. The second phase is for efficacy expansion through randomization.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503888
- Sponsor's protocol ID
- SHR-1701-215
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study of Almonertinib Combined With SHR-1701 or Other Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation
- ClinicalTrials.gov ID
- NCT05503888
- Acronym / sponsor ID
- SHR-1701-215
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Aug 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.
To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a multicenter, open-label, dose-exploring, and efficacy expansion phase Ib/II study. The first phase explored two doses of SHR-1701 plus fixed dose of almonertinib to confirm RP2D. The second phase is for efficacy expansion through randomization.
| Arm | Type | Receives |
|---|---|---|
| Almonertinib combined with SHR-1701 | Experimental | Drug: Almonertinib combined with SHR-1701 |
| Almonertinib | Placebo comparator | Drug: Almonertinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients voluntarily joined the study and signed informed consent
- Age 18~75 years old, both male and female
- Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
- At least one measurable lesion based on RECIST v1.1 criteria
- ECOG PS score: 0-1
Key exclusion criteria (14 listed)
- Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
- Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
- Suffering from other malignant tumors in the past 3 years or at the same time
- Presence of any active or known autoimmune disease
- Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (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 |
|---|---|---|
| Almonertinib combined with SHR-1701Phase Ⅰb/Phase Ⅱ： SHR-1701: injection, intravenous infusion Almonertinib: tablets, oral | Drug | Almonertinib combined with SHR-1701 |
| AlmonertinibPhase Ⅱ: Almonertinib: tablets, oral | Drug | Almonertinib |
Primary outcome
Dose limiting toxicity （Phase Ib）
Time frame: 21 days after the first dose
The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib）
Time frame: from the time when all informed subjects signed the informed consent to the end of the safety follow-up period
PFS rate at 12 months
Time frame: 12 months after the first medication for the last subject
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
8 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: up to 3 years
Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial
Time frame: up to 3 years
ORR
Time frame: up to 3 years
DCR
Time frame: up to 3 years
DoR
Time frame: up to 3 years
DepOR
Time frame: up to 3 years
PFS
Time frame: up to 3 years
OS
Time frame: up to 5 years
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 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Relapsed or Advanced Non-small Cell Lung Cancer
RecruitingPhase 1/2
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer
RecruitingPhase 1/2
Evaluation of XYA02 in Patients With Advanced Solid Tumors
MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors
Advanced Solid Tumors
Active, not recruitingPhase 1
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
Solid Tumor
Enrolling by invitationPhase 1
A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4
Non Small Cell Lung Cancer, Cervical Cancer
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Almonertinib combined with SHR-1701 and Almonertinib in people with Relapsed or Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
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 7 inclusion and 14 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yanbo Liu (0518-82342973, yanbo.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity （Phase Ib） (time frame: 21 days after the first dose). The study lists 3 primary outcomes in all. 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 17 Aug 2022.