Lung Cancer Non-small Cell Stage IVPhase 3NCT03866993
A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer
A Phase 3 study testing AK105, Paclitaxel and Carboplatin in people with Lung Cancer Non-small Cell Stage IV and Squamous Cell Lung Cancer, run by Akeso at 2 sites in China.
Trial summary
This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer Non-small Cell Stage IV, Squamous Cell Lung Cancer
- What is being tested?
- AK105, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 2 sitesChina
- Study dates
- 20 Dec 2018to 14 Jan 2022
- Phase
- Phase 3
- 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
- Signed written informed consent form voluntarily.
- Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Expected life expectance ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IV squamous NSCLC.
- No prior systemic chemotherapy for advanced or metastatic NSCLC. Subjects who have received prior adjuvant chemotherapy or neoadjuvant chemotherapy with curative intent, or definitive chemoradiotherapy for advanced disease, will be eligible provided that progression has occurred >6 months from last treatment.
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- At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated will not be considered a target lesion.
- Subjects must provide an available tumor tissue sample taken < 6 months prior to first dose of study treatment.
- Adequate organ function.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
Who cannot join
- Subjects who are diagnosed as NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
- Subjects with other histological types of NSCLC, including mixed squamous cell carcinoma and adenocarcinoma, and mixed carcinoma containing small cell lung carcinoma or neuroendocrine carcinoma.
- Received prior treatment with EGFR inhibitors or ALK inhibitors.
- Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 3 weeks prior to the first dose of study treatment.
- Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
- Other invasive malignancies within 5 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
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- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
- Subjects who require systemic corticosteroids (a dose equivalent to >10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
- Major surgery (as defined by the investigator) within 28 days prior to the first dose of study drug.
- Subjects who received non-thoracic radiotherapy >30 Gy within 4 weeks prior to the first dose, or thoracic radiotherapy >30 Gy within 24 weeks prior to the first dose study drug.
- History of gastrointestinal perforation and/ or fistula within 6 months prior to the first dose of study drug.
- Known history of primary immunodeficiency virus infection.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease.
- Known history of active tuberculosis (TB).
- Serious infections within 4 weeks prior to the first dose of study drug, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
- An active infection requiring systemic therapy.
- Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
- Known history of testing positive for human immunodeficiency virus (HIV).
- Presence of central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Clinically active hemoptysis, active diverticulitis, peritoneal abscess, or gastrointestinal obstruction.
- Clinically significant bleeding symptoms or significant bleeding tendency such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis within 1 month prior to the first dose of study treatment.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
- Receipt of live or attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live or attenuated vaccine during the study.
- Known history of server hypersensitivity to other monoclonal antibodies.
- Known severe allergic reactions to paclitaxel, carboplatin, or their preventive medications.
- Grade 2 or greater peripheral neuropathy (based on NCI CTCAE v4.03 criteria)
- Known allergic reactions to any ingredients of AK105.
- Pregnant or lactating women.
- Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of study results.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Paclitaxel vs Placebo Combined With Carboplatin and Paclitaxel as First-line Therapy in Patients With Metastatic Squamous Non-small Cell Lung Cancer
This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.
- Being tested
- AK105, Paclitaxel, Carboplatin, Placebo
- Keywords
- immuno-oncology, NSCLC, Anti-PD-1 Antibody, immunotherapy
- 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.
AK105Biological
IV infusion
PaclitaxelDrug
IV infusion
CarboplatinDrug
IV infusion
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| AK105 plus Carboplatin and Paclitaxel | Experimental | Subjects receive AK105 200 mg intravenously (IV) plus Paclitaxel 175mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK105 200 mg IV Q3W until progression. Receives: Biological: AK105; Drug: Paclitaxel; Drug: Carboplatin |
| placebo plus Carboplatin and Paclitaxel | Placebo comparator | Subjects receive placebo intravenously (IV) plus Paclitaxel 175mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK105 200 mg IV Q3W until progression. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) in intent-to-treat (ITT) population, assessed by Independent Radiologist Review Committee(IRRC) in accordance with RECIST v1.1
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by IRRC or death due to any cause (whichever occurs first).
Measured: Up to approximately 2 years
PFS in PD-L1-selected population, assessed by IRRC in accordance with RECIST v1.1
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by IRRC or death due to any cause (whichever occurs first).
Measured: Up to approximately 2 years
Secondary outcomes (9)
Overall survival (OS) in ITT population
OS is the time from the date of randomization to death due to any cause.
Measured: Up to approximately 2 years
Overall survival (OS) in PD-L1-selected population
OS is the time from the date of randomization to death due to any cause.
Measured: Up to approximately 2 years
PFS assessed by the investigator in accordance with RECIST v1.1
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Measured: Up to approximately 2 years
Incidence and severity of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.
Measured: From the time of informed consent signed through 90 days after last dose of AK105
Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Measured: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From first dose of AK105 through 90 days after last dose of AK105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start20 Dec 2018
- Primary completion8 Oct 2020
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Non-small Cell Stage IVStudies of the same condition, open and under way.
- More trials run by AkesoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Responsible party
- Sponsor
- Investigators
- Shunchang Jiao, MD, Study chair, Chinese PLA General HospitalBaohui Han, MD, Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866993
- Sponsor's protocol ID
- AK105-302
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhong H, Sun S, Chen J, Wang Z, Zhao Y, Zhang G, Chen G, Zhou M, Zhou J, Du Y, Wu L, Xu Z, Mei X, Zhang W, He J, Cui J, Zhang Z, Luo H, Liu W, Sun M, Wu J, Shen Y, Zhang S, Yang N, Wang M, Lu J, Li K, Yao W, Sun Q, Yue H, Wang L, Ye S, Li B, Zhuang X, Pan Y, Zhang M, Shu Y, He Z, Pan L, Ling Y, Liu S, Zhang Q, Jiao S, Han B. First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. Lancet Respir Med. 2024 May;12(5):355-365. doi: 10.1016/S2213-2600(23)00431-9. Epub 2024 Jan 31.
PubMed 38309287
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Paclitaxel vs Placebo Combined With Carboplatin and Paclitaxel as First-line Therapy in Patients With Metastatic Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03866993
- Acronym / sponsor ID
- AK105-302
- Keywords
- immuno-oncology, NSCLC, Anti-PD-1 Antibody, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 7 Mar 2019 (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 phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK105 plus Carboplatin and Paclitaxel | Experimental | Biological: AK105, Drug: Paclitaxel, Drug: CarboplatinSubjects receive AK105 200 mg intravenously (IV) plus Paclitaxel 175mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK105 200 mg IV Q3W until progression. |
| placebo plus Carboplatin and Paclitaxel | Placebo comparator | Drug: Paclitaxel, Drug: Carboplatin, Drug: PlaceboSubjects receive placebo intravenously (IV) plus Paclitaxel 175mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK105 200 mg IV Q3W until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent form voluntarily.
- Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Expected life expectance ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IV squamous NSCLC.
Key exclusion criteria (32 listed)
- Subjects who are diagnosed as NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
- Subjects with other histological types of NSCLC, including mixed squamous cell carcinoma and adenocarcinoma, and mixed carcinoma containing small cell lung carcinoma or neuroendocrine carcinoma.
- Received prior treatment with EGFR inhibitors or ALK inhibitors.
- Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 3 weeks prior to the first dose of study treatment.
- Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
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 |
|---|---|---|
| AK105IV infusion | Biological | AK105 plus Carboplatin and Paclitaxel |
| PaclitaxelIV infusion | Drug | AK105 plus Carboplatin and Paclitaxel, placebo plus Carboplatin and Paclitaxel |
| CarboplatinIV infusion | Drug | AK105 plus Carboplatin and Paclitaxel, placebo plus Carboplatin and Paclitaxel |
| PlaceboIV infusion | Drug | placebo plus Carboplatin and Paclitaxel |
Primary outcome
Progression-free survival (PFS) in intent-to-treat (ITT) population, assessed by Independent Radiologist Review Committee(IRRC) in accordance with RECIST v1.1
Time frame: Up to approximately 2 years
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by IRRC or death due to any cause (whichever occurs first).
PFS in PD-L1-selected population, assessed by IRRC in accordance with RECIST v1.1
Time frame: Up to approximately 2 years
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by IRRC or death due to any cause (whichever occurs first).
9 secondary outcomes
Overall survival (OS) in ITT population
Time frame: Up to approximately 2 years
Overall survival (OS) in PD-L1-selected population
Time frame: Up to approximately 2 years
PFS assessed by the investigator in accordance with RECIST v1.1
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: From the time of informed consent signed through 90 days after last dose of AK105
Observed concentrations of AK105
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 38309287Zhong H, Sun S, Chen J, Wang Z, Zhao Y, Zhang G, Chen G, Zhou M, Zhou J, Du Y, Wu L, Xu Z, Mei X, Zhang W, He J, Cui J, Zhang Z, Luo H, Liu W, Sun M, Wu J, Shen Y, Zhang S, Yang N, Wang M, Lu J, Li K, Yao W, Sun Q, Yue H, Wang L, Ye S, Li B, Zhuang X, Pan Y, Zhang M, Shu Y, He Z, Pan L, Ling Y, Liu S, Zhang Q, Jiao S, Han B. First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. Lancet Respir Med. 2024 May;12(5):355-365. doi: 10.1016/S2213-2600(23)00431-9. Epub 2024 Jan 31.
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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.
Shunchang Jiao, MD study chair
Chinese PLA General Hospital
Baohui Han, MD study chair
Shanghai Chest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK105, Paclitaxel and Carboplatin in people with Lung Cancer Non-small Cell Stage IV and Squamous Cell Lung Cancer, run by Akeso at 2 sites 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 32 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: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (PFS) in intent-to-treat (ITT) population, assessed by Independent Radiologist Review Committee(IRRC) in accordance with RECIST v1.1 (time frame: Up to approximately 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 NCT03866993, which also lists 1 linked publication.
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 3 Apr 2024.