Non-Small Cell Lung CancerPhase 3NCT05116462
Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer
A Phase 3 study testing Pemetrexed, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC). 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?
- Pemetrexed, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 14 Oct 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
- Age ≥ 18 years.
- Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
- Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
- Deemed radically resectable with curative intent.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.
Who cannot join
- Subjects with confirmed or suspected brain metastases.
- Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
- Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
- Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
- Requiring long term systemic corticosteroids
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
- Active hepatitis B.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)
This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed, Carboplatin, Paclitaxel, Sintilimab, Cisplatin
- 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.
PemetrexedDrug
500 mg/m2 D1 IV Q3W
CarboplatinDrug
AUC 5 or 6 mg/ml/min D1 IV Q3W
PaclitaxelDrug
175 or 200 mg/m2 D1 IV Q3W
SintilimabDrug
200 mg D1 IV Q3W
CisplatinDrug
75 mg/m2 D1 IV Q3W
Nab paclitaxelDrug
100 mg/m2 D1, 8, 15 IV Q3W
PlaceboDrug
20 ml D1 IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab | Experimental | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Sintilimab; Drug: Cisplatin; Drug: Nab paclitaxel |
| Placebo | Placebo comparator | Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Nab paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS) in stage III NSCLC
Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Measured: Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event Free Survival (EFS) in ITT population
EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.
Measured: Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years )
Secondary outcomes (4)
Disease free survival (DFS)
DFS is defined as the time from surgery to disease recurrence or death due to any cause.
Measured: Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years )
Major Pathological Response (mPR) Rat
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Measured: Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years)
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5.4 years
Safety parameters:AE
The relationship of study drug and the severity of all adverse events (AEs), treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), immune-related adverse events (irAEs), serious adverse events (SAEs), infusion-related reactions (IRRs) and surgery delay rate.
Measured: Up to approximately 5.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start15 Mar 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion14 Oct 2028 (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 Innovent Biologics (Suzhou) 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116462
- Sponsor's protocol ID
- CIBI308G301
- Status last verified
- Jun 2025
- First submitted
- 26 Oct 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)
- ClinicalTrials.gov ID
- NCT05116462
- Acronym / sponsor ID
- CIBI308G301
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 11 Nov 2021 (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 study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab | Experimental | Drug: Pemetrexed, Drug: Carboplatin, Drug: Paclitaxel, Drug: Sintilimab, Drug: Cisplatin, Drug: Nab paclitaxelNeoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
| Placebo | Placebo comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: Paclitaxel, Drug: Cisplatin, Drug: Nab paclitaxel, Drug: PlaceboNeoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
- Age ≥ 18 years.
- Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
- Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
- Deemed radically resectable with curative intent.
Key exclusion criteria (7 listed)
- Subjects with confirmed or suspected brain metastases.
- Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
- Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
- Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
- Requiring long term systemic corticosteroids
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 |
|---|---|---|
| Pemetrexed500 mg/m2 D1 IV Q3W | Drug | Placebo, Sintilimab |
| CarboplatinAUC 5 or 6 mg/ml/min D1 IV Q3W | Drug | Placebo, Sintilimab |
| Paclitaxel175 or 200 mg/m2 D1 IV Q3W | Drug | Placebo, Sintilimab |
| Sintilimab200 mg D1 IV Q3W | Drug | Sintilimab |
| Cisplatin75 mg/m2 D1 IV Q3W | Drug | Placebo, Sintilimab |
| Nab paclitaxel100 mg/m2 D1, 8, 15 IV Q3W | Drug | Placebo, Sintilimab |
| Placebo20 ml D1 IV Q3W | Drug | Placebo |
Primary outcome
Event Free Survival (EFS) in stage III NSCLC
Time frame: Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event Free Survival (EFS) in ITT population
Time frame: Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years )
EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.
4 secondary outcomes
Disease free survival (DFS)
Time frame: Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years )
Major Pathological Response (mPR) Rat
Time frame: Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years)
Overall survival (OS)
Time frame: Up to approximately 5.4 years
Safety parameters:AE
Time frame: Up to approximately 5.4 years
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 26 Jun 2025.
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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 3 study testing Pemetrexed, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. 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. 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?
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?
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?
Event Free Survival (EFS) in stage III NSCLC (time frame: Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 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?
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 26 Jun 2025.