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Non-small Cell Lung CancerPhase 1NCT05555212

To Evaluate the Efficacy of QLH11811 in Advanced NSCLC Patients With EGFR Mutation

A Phase 1 study testing QLH11811 in people with Non-small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 1, open-label, dose escalation and cohort expansion study and conducted in China and the United States to investigate the safety, tolerability and preliminary efficacy of QLH11811 in advanced or metastatic NSCLC patients who have progressed after prior EGFR-TKI treatment. 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?
QLH11811
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
25 Oct 2022to 31 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who participate voluntarily, sign informed consent form (ICF), and will be able to follow the study procedures;
  • Aged ≥ 18 years;
  • Patients who are histologically or cytologically diagnosed with EGFR mutation and have unresectable locally advanced or recurrent/metastatic NSCLC;
  • EGFR mutation requirements:
  • Dose escalation phase (phase 1a): NSCLC patients who have progressed after standard EGFR-TKI treatment or cannot tolerate standard of care;
  • Cohort expansion phase (phase 1b):
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  • Cohort 1: advanced NSCLC patients who have progressed after treatment with third-generation EGFR-TKIs and have EGFR C797S mutation.
  • Cohort 2: advanced NSCLC patients who have progressed after standard EGFR-TKI treatment but have no other additional driver gene mutation(s).
  • Cohort 3: advanced NSCLC patients who have progressed after EGFR-TKI treatment and have T790M mutation.
  • Cohort 4: patients with locally progressed, unresectable or recurrent metastatic NSCLC who are naive to EGFR-TKI treatment and have 19del or 21L858R mutation among EGFR sensitive mutations.
  • Patients who agree to provide tumor samples (fresh tissues or archived samples) for analysis of EGFR gene.
  • Dose escalation phase: tumor samples collected from the progression site of disease during or after PD after the last TKI treatment should be provided for new genetic testing The subjects who fail to provide tumor samples will be allowed to enroll only after communication and consultation with the sponsor.
  • Cohort expansion phase:
  • Cohort1: tumor samples collected from the progression site of disease during or after PD after the last TKI treatment should be provided for genetic testing at central laboratory.
  • Cohorts 2 and 3: tumor samples collected from the progression site of disease during or after PD after the last TKI treatment should be provided for genetic testing. The genetic testing will be exempted if subjects have the test results meeting the above requirements before their enrollment.
  • Cohort 4: tumor samples collected from the progression site of disease during or after PD after the last treatment should be provided for genetic testing (of EGFR mutation); and if subjects are treatment-naive, they will be required to provide the tumor samples only during the screen period. The genetic testing will be exempted if subjects have the test results meeting the above requirements before their enrollment.
  • ECOG ≤ 1 point (for details, refer to Appendix 2 ECOG performance status score);
  • Life expectancy ≥ 12 weeks;
  • Patients who have been diagnosed according to RECIST v1.1 and have measurable lesions as documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) (note: subjects who do not have measurable lesions are allowed to be enrolled in phase 1a study). Note: a measurable lesion for response evaluation has to meet the following criteria: a) it is not in an area that has been involved in prior radiotherapy, or b) there is notable radiographic evidence of progression after the completion of radiotherapy and before study enrollment;
  • Patients who have adequate organ functions and meet the following criteria:
  • Hematology:
  • Absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L (no blood transfusion and no use of granulocyte colony stimulating factor in the 14 days prior to the screening);
  • Coagulation:
  • For patients who have not received anticoagulant therapy: international normalized ratio (INR) of prothrombin time and partial thromboplastin time ≤ 1.5 × ULN;
  • Liver:
  • Alanine aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3.0 × ULN. For patients with liver metastases: ALT and AST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN. For patients with Gilbert syndrome: conjugated bilirubin within normal range;
  • Kidney:
  • Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula, refer to Appendix 4 Creatinine clearance calculation formula).
  • All acute toxic reactions arising from prior antineoplastic therapy or surgery have resolved to baseline or reduced in severity to ≤ Grade 1 according to NCI CTCAE V5.0 (except for alopecia or other toxicities which, in the opinion of the investigator, pose no safety risk to the patient);
  • Patients (both female and male) who agree to take effective contraceptive measures from their signing of ICF to 6 months after the last dose of the study drug. For women of childbearing potential: negative serum pregnancy test result in 7 days prior to the start of treatment is required.

Who cannot join

  • Patients who have received systemic anticancer therapies (e.g., chemotherapy, molecularly targeted therapy, radiotherapy, biotherapy, hormone therapy, vaccine therapy), or antineoplastic TCM therapy in the 2 weeks prior to the first dose of study treatment; or who have received immune-checkpoint inhibitor therapy in the 4 weeks prior to the first dose of study treatment;
  • Patients who have received radical radiotherapy (including radiotherapy of more than 25% of bone marrow) in the 4 weeks prior to the first dose, or who have received local palliative radiotherapy for bone metastatic lesions in the 1 week prior to the first dose;
  • Patients who have received strong or moderate CYP3A, P-gp inhibitors in the 1 week prior to the first dose or in 5 half-lives of these drugs (whichever is longer), or need to continue to receive these drugs during the study; and who have received strong or moderate CYP2B6, CYP1A2 and CYP3A inducers in the 4 weeks prior to the first dose;
  • Patients who are in the treatment period of other interventional clinical studies in the 4 weeks prior to the first dose. However, participants of non-interventional clinical studies (e.g., epidemiologic studies) are eligible for enrollment in this study. Patients in the survival follow-up period of interventional clinical studies are also eligible for enrollment in this study;
  • Patients who have active bacterial, fungal or viral infection requiring systemic therapies within the 1 week prior to the first dose;
  • Patients who have underwent a major operation (e.g., a surgical operation requiring local or general anesthesia and hospitalization) in the 3 weeks prior to the start of study treatment;
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  • Patients with a history of chronic diarrhea, including but not limited to Crohn's disease, irritable bowel syndrome, etc.;
  • Patients who have experienced > CTCAE Grade 1 continuous diarrhea within the 1 week prior to the first dose;
  • Patients with serious respiratory disorders, e.g. interstitial lung disease, radiation pneumonitis, drug-induced pneumonia (however, patients whose conditions have resolved and stabilized for 3 months or more are eligible for enrollment);
  • Patients with symptomatic metastasis to central nervous system (CNS) and/or with meningitis carcinomatosa.
  • Note: patients with brain metastases whose clinical symptoms have stabilized after treatment are eligible for participation in the study, provided that their conditions are radiographically stabilized (defined as stability demonstrated by 2 brain images acquired by the same imaging technique after treatment of brain metastases). These imaging scans should be carried out at an interval of at least 4 weeks, and show no signs of intracranial progression. Furthermore, brain metastases or its treatment induced neurologic symptoms need to regress to baseline level or resolve. All steroids administered as a part of the treatment must be completed ≥ 3 days prior to the administration of study treatment.
  • Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:
  • Myocardial infarction or unstable angina in the 6 months prior to the first dose;
  • Stroke or transient ischemic attack in the 6 months prior to the first dose;
  • Any clinically significant abnormalities in resting ECG in terms of cardiac rhythm, heart rate, conduction or morphology, e.g. complete left bundle branch block, third-degree conduction block, second-degree conduction block, PR interval > 250 ms, etc.;
  • Uncontrolled hypertension after active treatment: systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg;
  • Congestive cardiac failure (NYHA functional class III-IV);
  • Pericarditis or clinically significant pericardial effusion;
  • Myocarditis;
  • 12-lead ECG shows that mean QT interval (QTcF) > 450 ms (male) or > 470 ms (female) before the first dose of investigational drug;
  • Failure to discontinue the drugs that may cause QTc prolongation or torsades de pointes (e.g., antiarrhythmics) during the study.
  • Patients with clinically uncontrolled serous effusion(e.g., pleural fluid that cannot be controlled by drainage or other methods).
  • Patients with active gastrointestinal disorders or other conditions that have serious interference with the drug absorption.
  • Patients with any condition that have an adverse impact on the swallowing of the drug or on the absorption or PK parameters of the investigational drug;
  • Patients with known serious allergy to the study drug or any excipient of the drug;
  • Patients with known HIV test positive result and/or treponema pallidum antibody test positive result (except for those whose infection has been cured after treatment).
  • Patients with HBsAg positive result and HBV DNA > 2000 IU/mL or 104 copies/mL (for sites which only provide the qualitative testing, HBV DNA test result is positive or higher than lower limit of detection); or with HCV antibody positive and HCV RNA positive results.
  • Patients who experienced other malignancies (with the exceptions of Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ) in the 2 years prior to the study enrollment.
  • Pregnant or lactating women. Lactating female subjects need to stop breast-feeding before the first dose of study treatment, which cannot be resumed throughout the study and in the 6 months after the last dose of study treatment.
  • Patients with any existing serious or unstable diseases (except for the above-mentioned malignancies), psychiatric disorders or any disease or medical condition which, in the investigator's opinion, may have an adverse impact on the subject safety, the signing of ICF or the compliance with the study procedures.
  • Patients who are currently participating in a clinical study of other investigational therapies.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Qilu Pharmaceutical.Co.,Ltd

    Jinan, Shandong, 273200

    kang, 0531-83126666, xiaoyan.kang@qilupharma.com

    Recruiting

Other trials in China

About this study

Official title: Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLH11811 in Advanced or Metastatic NSCLC Patients Who Have Progressed After EGFR-TKI Treatment

This is a phase 1, open-label, dose escalation and cohort expansion study and conducted in China and the United States to investigate the safety, tolerability and preliminary efficacy of QLH11811 in advanced or metastatic NSCLC patients who have progressed after prior EGFR-TKI treatment. The study consists of the following 2 phases: phase 1: dose escalation (1a) and phase 2: cohort expansion (1b).

Being tested
QLH11811
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.

  • QLH11811Drug

    In Ia phase, subjects will first receive oral single dose of QLH11811, then will be observed for 7 days. If the drug is tolerated by the subjects, the subjects will continue to receive the oral repeat dose of QLH11811 for 21 consecutive days. Upon the completion of observation for DLT in the subjects (DLT observation period is the 28 days after the first dose), the subjects will continue to receive the repeat dose of QLH11811 in Cycle 2 and subsequent cycles. The dosing frequency in Cycle 2 and subsequent cycles is once daily, and each cycle has 3 weeks.

    The RP2D of QLH11811 is determined on the basis of comprehensive evaluation of all safety and tolerability data and all available PK, PD and efficacy data during the dose escalation phase. In phase 1b, the cohort expansion study is carried out for all cohorts in China and the United States concurrently according to the determined RP2D.

Study groups in NCT05555212
Study groupRoleWhat they receive
dose escalation (in China)ExperimentalNot described
Receives: Drug: QLH11811

What is being measured

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

  1. Safety parameters

    adverse events (AEs), serious adverse events (SAEs) and other safety results

    Measured: 2 years

  2. ORR

    Objective response rate (ORR) (evaluated by the Independent Review Committee in NSCLC patients who have EGFR-C797S mutation according to RECIST v1.1).

    Measured: 2 years

Secondary outcomes (1)

  1. Possible metabolites of QLH11811 in plasma

    QLH11811 metabolites that may be present in the blood were detected

    Measured: 6 month

Timeline

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

  1. First posted26 Sep 2022
  2. Study start25 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a phase 1, open-label, dose escalation and cohort expansion study and conducted in China and the United States to investigate the safety, tolerability and preliminary efficacy of QLH11811 in advanced or metastatic NSCLC patients who have progressed after prior EGFR-TKI treatment. The study consists of the following 2 phases: phase 1: dose escalation (1a) and phase 2: cohort expansion (1b), as detailed in Overall Schematic of Study Design. Phase 1a: this dose escalation study will be conducted in China and the United States, respectively, and the dose escalation will start from starting dose in China and from dose level next to the MTD determined in Chinese subjects in the United States. Phase 1b: after the determination of RP2D, this cohort expansion study will be conducted in China and the United States concurrently to observe the safety, tolerability and efficacy of QLH11811 in advanced NSCLC patients who have EGFR mutation
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555212
Sponsor's protocol ID
QLH11811
Status last verified
Sep 2022
First submitted
23 Aug 2022
Last updated
28 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QLH11811 in people with Non-small Cell Lung Cancer, run by Qilu 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 30 inclusion and 31 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 28 Mar 2023. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety parameters (time frame: 2 years). 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?

On the ClinicalTrials.gov record for NCT05555212.

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 28 Mar 2023.

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