Non-Squamous Non-Small Cell Lung CancerPhase 3NCT03802240

Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

A Phase 3 study testing Sintilimab, IBI305 and Pemetrexed in people with Non-Squamous Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Squamous Non-Small Cell Lung Cancer
What is being tested?: Sintilimab, IBI305 and Pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 492 participants
Where: 1 siteChina
Study dates: 11 Jul 2019to 30 Jun 2023
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

None listed.

Who cannot join

Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
Has previously received systemic anti-tumor treatment other than EGFR-TKI for or advanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);
Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
Has received EGFR-TKI treatment within 2 weeks;
Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;

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Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
Hemoptysis within 3 months,
Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Conditions: Non-Squamous Non-Small Cell Lung Cancer
Being tested: Sintilimab, IBI305, Pemetrexed, Cisplatin, Placebo1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SintilimabDrug
Also called IBI308
200mg IV Q3W
IBI305Drug
15mg/kg IV Q3W
PemetrexedDrug
500mg/m2 IV Q3W
CisplatinDrug
75mg/m2 IV Q3W
Placebo1Drug
Placebo1 IV Q3W
Placebo2Drug
Placebo2 IV Q3W

Study groups in NCT03802240
Study group	Role	What they receive
Sintilimab +IBI305+Pemetrexed+Cisplatin	Experimental	Drug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: IBI305 15mg/kg IV Q3W Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Receives: Drug: Sintilimab; Drug: IBI305; Drug: Pemetrexed; Drug: Cisplatin
Sintilimab +Placebo2+Pemetrexed+Cisplatin	Experimental	Drug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Receives: Drug: Sintilimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Placebo2
Placebo1+Placebo2+Pemetrexed+Cisplatin	Active comparator	Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Placebo1; Drug: Placebo2

What is being measured

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

PFS (Progression Free Survival)
Measured: Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month

Secondary outcomes (6)

OS (Overall Survival)
Measured: Time from randomization to the death of the subject due to any cause assessed up to 36 months.
ORR (overall response rate)
Measured: The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months.
PFS (Progression Free Survival)
Measured: Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month.
DCR(Disease control rate )
Measured: The proportion of subjects in the analysis population who had a complete response (CR) or partial response (PR) or stable disease (SD) up to 24 month.
TTR（Time to objective response )
Measured: For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month.
DOR(Duration of response)
Measured: For subjects with CR or PR, defined as the time from the first documented CR or PR to disease progression or death up to 24 month.

Timeline

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

11 Jul 201930 Jun 2023

First posted14 Jan 2019
Study start11 Jul 2019
Primary completion31 Jul 2021
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Non-Squamous 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 492 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03802240
Sponsor's protocol ID: CIBI338A301
Status last verified: Nov 2023
First submitted: 7 Jan 2019
Last updated: 27 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5.
PubMed 37156249
Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28.
PubMed 35908558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-Squamous Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)
ClinicalTrials.gov ID: NCT03802240
Acronym / sponsor ID: CIBI338A301
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 492 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 11 Jul 2019 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 14 Jan 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.

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Sintilimab +IBI305+Pemetrexed+Cisplatin	Experimental	Drug: Sintilimab, Drug: IBI305, Drug: Pemetrexed, Drug: CisplatinDrug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: IBI305 15mg/kg IV Q3W Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W
Sintilimab +Placebo2+Pemetrexed+Cisplatin	Experimental	Drug: Sintilimab, Drug: Pemetrexed, Drug: Cisplatin, Drug: Placebo2Drug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo2 Placebo2 IV Q3W
Placebo1+Placebo2+Pemetrexed+Cisplatin	Active comparator	Drug: Pemetrexed, Drug: Cisplatin, Drug: Placebo1, Drug: Placebo2Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
Has previously received systemic anti-tumor treatment other than EGFR-TKI for or advanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);
Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
Has received EGFR-TKI treatment within 2 weeks;
Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.

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
SintilimabAlso: IBI308200mg IV Q3W	Drug	Sintilimab +IBI305+Pemetrexed+Cisplatin, Sintilimab +Placebo2+Pemetrexed+Cisplatin
IBI30515mg/kg IV Q3W	Drug	Sintilimab +IBI305+Pemetrexed+Cisplatin
Pemetrexed500mg/m2 IV Q3W	Drug	Placebo1+Placebo2+Pemetrexed+Cisplatin, Sintilimab +IBI305+Pemetrexed+Cisplatin, Sintilimab +Placebo2+Pemetrexed+Cisplatin
Cisplatin75mg/m2 IV Q3W	Drug	Placebo1+Placebo2+Pemetrexed+Cisplatin, Sintilimab +IBI305+Pemetrexed+Cisplatin, Sintilimab +Placebo2+Pemetrexed+Cisplatin
Placebo1Placebo1 IV Q3W	Drug	Placebo1+Placebo2+Pemetrexed+Cisplatin
Placebo2Placebo2 IV Q3W	Drug	Placebo1+Placebo2+Pemetrexed+Cisplatin, Sintilimab +Placebo2+Pemetrexed+Cisplatin

Primary outcome

PFS (Progression Free Survival)
Time frame: Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month

6 secondary outcomes

OS (Overall Survival)
Time frame: Time from randomization to the death of the subject due to any cause assessed up to 36 months.
ORR (overall response rate)
Time frame: The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months.
PFS (Progression Free Survival)
Time frame: Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month.
DCR(Disease control rate )
Time frame: The proportion of subjects in the analysis population who had a complete response (CR) or partial response (PR) or stable disease (SD) up to 24 month.
TTR（Time to objective response )
Time frame: For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month.
DOR(Duration of response)
Time frame: For subjects with CR or PR, defined as the time from the first documented CR or PR to disease progression or death up to 24 month.

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 27 Nov 2023.
Derived from this study: PubMed 37156249Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5.
Derived from this study: PubMed 35908558Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28.

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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 Sintilimab, IBI305 and Pemetrexed in people with Non-Squamous 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 0 inclusion and 9 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 27 Nov 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 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?

PFS (Progression Free Survival) (time frame: Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month). 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 NCT03802240, which also lists 2 linked publications.

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 27 Nov 2023.