Non Small Cell Lung CancerPhase 1/2NCT06507891
A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets
A Phase 1/2 study testing TQ-A3334 tablets and TQ-A3334 tablets + Anlotinib capsules in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules in patients with non-small cell lung cancer. 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?
- TQ-A3334 tablets and TQ-A3334 tablets + Anlotinib capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 4 Jun 2024
- Phase
- Phase 1/2
- 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
- Understood and signed an informed consent form;
- 18 years old and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; life expectancy ≥12 weeks;
- Histologically confirmed advanced non-small cell lung cancer;
- Has received at least two systemic chemotherapy regimens which is failure or intolerance；
- At least one measurable lesion（ based on Response evaluation criteria in solid tumors (RECIST) 1.1;
- The main organs function are normally；
- Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization；
- In addition to the above criteria, the extended research phase must meet the following criteria: epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) are negative; or patients with positive test results of EGFR and ALK are resistant or intolerant after receiving the targeted drug treatment.
Who cannot join
- Small cell lung cancer
- Other malignant tumors that have appeared or are presently present within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks
- Expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period
- Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
- Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first administration
Show all 19Show fewer
- Hypersensitivity to TQ-A3334 or its excipient
- Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis
- Has unrelieved toxicity reactions ≥ grade 1 due to previous treatment
- Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear
- Has thyroid dysfunction that requires drug treatment within 6 months before the first administration
- Has multiple factors affecting oral medication
- Has any severe acute complications before the first administration
- Have participated in other clinical trials within 4 weeks before the first administration
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study
- In addition to the above criteria, the extended research phase must meet the following criteria:
- Pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis;
- EGFR and ALK are positive untreated with relevant targeted drugs;
- Has received anlotinib hydrochloride capsules.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer
This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules in patients with non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- TQ-A3334 tablets, TQ-A3334 tablets + Anlotinib capsules
- 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.
TQ-A3334 tabletsDrug
TQ-A3334 is a highly efficient and highly selective Toll-like receptor-7 (TLR-7) agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including interferon alpha (IFN-α), Interleukin 12 (IL-12), Tumor Necrosis Factor Alpha (TNF-α), and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.
TQ-A3334 tablets + Anlotinib capsulesDrug
TQ-A3334 is a highly efficient and highly selective TLR-7 agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including IFN-α (interferon-α), IL-12 (Interleukin 12), TNF-α, and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQ-A3334 tablets | Experimental | TQ-A3334 tablets administered orally on day 1, 8, 15 in 21-day cycle. Receives: Drug: TQ-A3334 tablets |
| TQ-A3334 tablets + Anlotinib capsules | Experimental | TQ-A3334 tablets administered orally on day1, 8, 15 in 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Receives: Drug: TQ-A3334 tablets + Anlotinib capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
The occurrence of adverse events and serious adverse events.
Measured: Baseline up to 21 days
Dose limited toxicity (DLT)
DLT defined as any of the following events occurring during the study related to drugs: (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days; (4) Immune-related interstitial pneumonia ≥ grade 2; (5) Decreased ventricular ejection fraction ≥ grade 2 ; (6) Retinal vein occlusion (RVO), uveitis ≥ grade 2.
Measured: Baseline up to 21 days
Maximum tolerable dose (MTD)
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
Measured: Baseline up to 21 days
Secondary outcomes (8)
Tmax
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
Measured: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Cmax
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Measured: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
t1/2
t1/2 is time it takes for the blood concentration of TQ-A3334 or metabolite(s) to drop by half.
Measured: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Area under the plasma concentration-time curve (AUC 0-t)
To characterize the pharmacokinetics of TQ-A3334 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Measured: Up to 96 weeks
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: Up to 96 weeks
Duration of Response (DOR)
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause.
Measured: Up to 96 weeks
Disease control rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start6 Jul 2020
- Primary completion25 Aug 2023
- Study completion4 Jun 2024
Why it stopped: After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507891
- Sponsor's protocol ID
- TQ-A3334-I-02
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 18 Jul 2024
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06507891
- Acronym / sponsor ID
- TQ-A3334-I-02
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 18 Jul 2024 (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 study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules in patients with non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQ-A3334 tablets | Experimental | Drug: TQ-A3334 tabletsTQ-A3334 tablets administered orally on day 1, 8, 15 in 21-day cycle. |
| TQ-A3334 tablets + Anlotinib capsules | Experimental | Drug: TQ-A3334 tablets + Anlotinib capsulesTQ-A3334 tablets administered orally on day1, 8, 15 in 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understood and signed an informed consent form;
- 18 years old and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; life expectancy ≥12 weeks;
- Histologically confirmed advanced non-small cell lung cancer;
- Has received at least two systemic chemotherapy regimens which is failure or intolerance；
- At least one measurable lesion（ based on Response evaluation criteria in solid tumors (RECIST) 1.1;
Key exclusion criteria (19 listed)
- Small cell lung cancer
- Other malignant tumors that have appeared or are presently present within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks
- Expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period
- Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
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 |
|---|---|---|
| TQ-A3334 tabletsTQ-A3334 is a highly efficient and highly selective Toll-like receptor-7 (TLR-7) agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including interferon alpha (IFN-α), Interleukin 12 (IL-12), Tumor Necrosis Factor Alpha (TNF-α), and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect. | Drug | TQ-A3334 tablets |
| TQ-A3334 tablets + Anlotinib capsulesTQ-A3334 is a highly efficient and highly selective TLR-7 agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including IFN-α (interferon-α), IL-12 (Interleukin 12), TNF-α, and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect. Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. | Drug | TQ-A3334 tablets + Anlotinib capsules |
Primary outcome
Adverse events (AE)
Time frame: Baseline up to 21 days
The occurrence of adverse events and serious adverse events.
Dose limited toxicity (DLT)
Time frame: Baseline up to 21 days
DLT defined as any of the following events occurring during the study related to drugs: (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days; (4) Immune-related interstitial pneumonia ≥ grade 2; (5) Decreased ventricular ejection fraction ≥ grade 2 ; (6) Retinal vein occlusion (RVO), uveitis ≥ grade 2.
Maximum tolerable dose (MTD)
Time frame: Baseline up to 21 days
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
8 secondary outcomes
Tmax
Time frame: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Cmax
Time frame: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
t1/2
Time frame: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Area under the plasma concentration-time curve (AUC 0-t)
Time frame: 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29
Overall response rate (ORR)
Time frame: Up to 96 weeks
Progression-free survival (PFS)
Time frame: Up to 96 weeks
Duration of Response (DOR)
Time frame: Up to 96 weeks
Disease control rate (DCR)
Time frame: Up to 96 weeks
Results and safety
The study was stopped early (reason given: After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQ-A3334 tablets and TQ-A3334 tablets + Anlotinib capsules in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 18 Jul 2024. 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 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?
The study was stopped early (reason given: After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.). Results are not available in the source record.
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?
Adverse events (AE) (time frame: Baseline up to 21 days). 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 18 Jul 2024.