Metastatic Non-Small Cell Lung CancerPhase 1NCT05223595
A Study of Gentuximab in Combination With Almonertinib in EGFR Mutation-positive Metastatic NSCLC
A Phase 1 study testing Gentuximab in people with Metastatic Non-Small Cell Lung Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a prospective, multicenter, open label study to investigate the safety and efficacy of Gentuximab plus Almonertinib in metastatic NSCLC patients with EGFR mutation-positive. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Gentuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to 30 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 8th edition).
- Phase Ib dose escalation Cohort: Previous genetic tests confirmed EGFR-sensitive mutations, and received one or two generations of EGFR TKI treatment. After drug resistance, it was confirmed to be positive for EGFR T790M mutation by biopsy or free DNA test.
- •Phase Ib expansion Cohort: Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation [exon 19 deletion or exon 21 (L858R) substitution mutation].
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
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- Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L; and platelet count ≥80×109/L.
- Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients or Gilbert's Syndrome (unconjugated hyperbilirubinemia) patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
- Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min.
- 24-hour urine protein quantitation is <1g（24-hour urine protein quantitative test should be performed when urine protein ≥2+ is found during screening visit）.
- A life expectancy of ≥12 weeks.
- Aged between 18 and 75 years
- Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Who cannot join
- History of other malignancies, excluding full treated non-melanoma skin cancer, in-situ cancer.
- Brain metastases unless asymptomatic, stable for at least 4 weeks, and not requiring steroids for at least 2 weeks prior to start of study treatment.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Interstitial lung disease
- Evidence of major coagulopathy or other obvious bleeding tendency，which， in the Investigator's opinion, makes it undesirable for the patient to participate in the trial
- Any of the following major cardiovascular disease： myocardial infarction or received coronary artery bypass graft within 6 months before the start of the study treatment uncontrolled congestive heart failure unstable angina within 6 months before the start of the study treatment any clinically important abnormalities in rhythm （sustained ventricular tachycardia, second degree heart block and third degree heart block）
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- Uncontrolled diabetes
- Uncontrolled hypertension (blood pressures: systolic≥140 mmHg and/or diastolic ≥90 mmHg)
- Uncontrolled third space effusion (pleural effusion and pericardial effusion need to be drained or increased rapidly after drained in three days) .
- Evidence of active tuberculosis
- Prior treatment with third generation EGFR-TKIs
- Previously administrated with anti-angiogenic drugs.
- Has received systematic anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose of investigational drug.
- Has received any biologics that targeted the immune system, such as TNF antagonist, anakinra, rituximab, abatacept and tocilizumab, etc. within 4 weeks before the first dose of investigational drug.
- Has received Chinese medicine with anti-cancer indications or immunomodulatory drugs （including thymosin，interferon，interleukin，except for the use of treatment for leural effusion）within 2 weeks before the first dose of investigational drug.
- Has received attenuated live vaccine with 12 weeks before the first dose of investigational drug or would receive attenuated live vaccine during the study (except of COVID-19 vaccines).
- Has received any other investigational drugs within 4 weeks before the first dose of investigational drug
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks before the first dose of drug.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy, video-assisted thoracic surgery, mediastinoscopy)，or would undergo planned surgery during the study.
- Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
- Has a known serious allergy reaction to EGFR-TKIs or anti-angiogenic drugs.
- Have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events V5.0 (CTCAE V5.0) grade 1 before the first dose of investigational drug, with the exception of alopecia.
- Chest radiotherapy within 4 weeks of the first dose of investigational drug or adverse reactions caused by radiotherapy have not recovered to ≤ CTCAE level 1 (except for alopecia).
- Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Shun Lu, +86-021-22200000 ext. 3403, shun_lu@hotmail.com
About this study
Official title: A Phase Ib Study to Investigate the Safety, Tolerability and Preliminary Antitumor Activity of Gentuximab in Combination With Almonertinib in Patients With EGFR Mutation-positive Metastatic Non-Small Cell Lung Cancer
This is a prospective, multicenter, open label study to investigate the safety and efficacy of Gentuximab plus Almonertinib in metastatic NSCLC patients with EGFR mutation-positive.
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Being tested
- Gentuximab
- 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.
GentuximabDrug
Also called Almonertinib
Gentuximab: 8mg/kg or 12mg/kg intravenous (IV) infusion administered on Day 1 and 15 of each cycle; Almonertinib: 110 mg orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | Gentuximab at a dose of 8 mg/kg or 12 mg/kg based on body weight + Almonertinib at a dose of 110mg for one 28-day cycle Receives: Drug: Gentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Number of participants with one or more drug-related adverse events (AEs) defined as DLT in the protocol
Measured: Up to 4 Weeks
AEs or SAEs
Drug-related adverse events (AEs) or any serious adverse events (SAEs)
Measured: Baseline through study completion, about 2 years
Secondary outcomes (6)
Cmax
Maximum Concentration
Measured: Cycle 1(day1-day 15)& Cycle 2(day 1-day15) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
AUC
Area Under the Concentration-Time Curve
Measured: Cycle 1(day1-day 15)& Cycle 2(day 1-day15) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
Objective response rate（ORR）
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Measured: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression)
Measured: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD
Measured: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Anti-drug antibody number of participants With Anti-drug Antibodies
Number of participants with anti-drug antibodies
Measured: Cycle 1(day1-day 15)& Cycle 2(day 1) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start2 Apr 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223595
- Sponsor's protocol ID
- Gensci043-Ib-LC
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Investigate the Safety, Tolerability and Preliminary Antitumor Activity of Gentuximab in Combination With Almonertinib in Patients With EGFR Mutation-positive Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05223595
- Acronym / sponsor ID
- Gensci043-Ib-LC
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 4 Feb 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.
This is a prospective, multicenter, open label study to investigate the safety and efficacy of Gentuximab plus Almonertinib in metastatic NSCLC patients with EGFR mutation-positive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: GentuximabGentuximab at a dose of 8 mg/kg or 12 mg/kg based on body weight + Almonertinib at a dose of 110mg for one 28-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 8th edition).
- Phase Ib dose escalation Cohort: Previous genetic tests confirmed EGFR-sensitive mutations, and received one or two generations of EGFR TKI treatment. After drug resistance, it was confirmed to be positive for EGFR T790M mutation by biopsy or free DNA test.
- •Phase Ib expansion Cohort: Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation [exon 19 deletion or exon 21 (L858R) substitution mutation].
- At least one Measurable lesion.
Key exclusion criteria (24 listed)
- History of other malignancies, excluding full treated non-melanoma skin cancer, in-situ cancer.
- Brain metastases unless asymptomatic, stable for at least 4 weeks, and not requiring steroids for at least 2 weeks prior to start of study treatment.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Interstitial lung disease
- Evidence of major coagulopathy or other obvious bleeding tendency，which， in the Investigator's opinion, makes it undesirable for the patient to participate in the trial
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 |
|---|---|---|
| GentuximabAlso: AlmonertinibGentuximab: 8mg/kg or 12mg/kg intravenous (IV) infusion administered on Day 1 and 15 of each cycle; Almonertinib: 110 mg orally once daily. | Drug | dose escalation |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: Up to 4 Weeks
Number of participants with one or more drug-related adverse events (AEs) defined as DLT in the protocol
AEs or SAEs
Time frame: Baseline through study completion, about 2 years
Drug-related adverse events (AEs) or any serious adverse events (SAEs)
6 secondary outcomes
Cmax
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 1-day15) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
AUC
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 1-day15) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
Objective response rate（ORR）
Time frame: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Progression-free survival (PFS)
Time frame: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Disease control rate (DCR)
Time frame: From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Anti-drug antibody number of participants With Anti-drug Antibodies
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 1) & Cycle 3(day 1) & Cycle 4(day 1) (28 days for every cycle)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
Shun Lu, Doctor principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gentuximab in people with Metastatic Non-Small Cell Lung Cancer, run by Changchun GeneScience Pharmaceutical 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 13 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Jin, Doctor (+86-18801970689, jinyunpeng@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: Up to 4 Weeks). The study lists 2 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 4 Feb 2022.