Non-small Cell Lung CancerPhase 2NCT05377658
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
A Phase 2 study testing AK104, Albumin-Bound Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- AK104, Albumin-Bound Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2022to 31 Dec 2027
- Phase
- Phase 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
- Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- Have adequate organ function.
Who cannot join
- Mixed NSCLC and small cell lung cancer histology.
- Patients with other active malignancies within 3 years prior to enrollment.
- Known active autoimmune diseases.
- Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- Presence of other uncontrolled serious medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Huijuan Wang, MD, 18638561588, 18638561588@163.com
About this study
Official title: A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- AK104, Albumin-Bound Paclitaxel, Carboplatin
- Keywords
- neoadjuvant and adjuvant therapy, bispecific antibody
- 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.
AK104Drug
Also called Cadonilimab
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Albumin-Bound PaclitaxelDrug
260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle.
CarboplatinDrug
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| AK104+albumin-bound paclitaxel+carboplatin | Experimental | Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles. Receives: Drug: AK104; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: At time of surgery
Secondary outcomes (6)
Major Pathological Response (MPR) Rate
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Measured: At time of surgery
Incidence of Surgical Complications
defined as ≥ grade 3 or severe intraoperative and perioperative complications.
Measured: Up to approximately 30 days following surgery
Complete (R0) Resection Rate
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Measured: After surgery (approximately 7 weeks)
Objective Response Rate (ORR)
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Measured: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)
Event Free Survival (EFS)
defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Measured: Up to approximately 5 years
Adverse Events (AEs)
Measured: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start26 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huijuan Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377658
- Sponsor's protocol ID
- AK104-IIT-005
- Status last verified
- Feb 2024
- First submitted
- 10 May 2022
- Last updated
- 21 Feb 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05377658
- Acronym / sponsor ID
- AK104-IIT-005
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- neoadjuvant and adjuvant therapy, bispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 May 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.
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104+albumin-bound paclitaxel+carboplatin | Experimental | Drug: AK104, Drug: Albumin-Bound Paclitaxel, Drug: CarboplatinParticipants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
- Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- Have adequate organ function.
Key exclusion criteria (5 listed)
- Mixed NSCLC and small cell lung cancer histology.
- Patients with other active malignancies within 3 years prior to enrollment.
- Known active autoimmune diseases.
- Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- Presence of other uncontrolled serious medical conditions.
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 |
|---|---|---|
| AK104Also: Cadonilimab10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. | Drug | AK104+albumin-bound paclitaxel+carboplatin |
| Albumin-Bound Paclitaxel260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle. | Drug | AK104+albumin-bound paclitaxel+carboplatin |
| CarboplatinAUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle. | Drug | AK104+albumin-bound paclitaxel+carboplatin |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At time of surgery
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
6 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At time of surgery
Incidence of Surgical Complications
Time frame: Up to approximately 30 days following surgery
Complete (R0) Resection Rate
Time frame: After surgery (approximately 7 weeks)
Objective Response Rate (ORR)
Time frame: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)
Event Free Survival (EFS)
Time frame: Up to approximately 5 years
Adverse Events (AEs)
Time frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
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 21 Feb 2024.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104, Albumin-Bound Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Feb 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 phase mean?
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 Huijuan Wang, MD (18638561588, 18638561588@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At time of surgery). 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 21 Feb 2024.