AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT03150875

A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC

A Phase 3 study testing IBI308 and Docetaxel in people with Non-small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 2 sites in China.

Completed

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

Official record
Search all trials

Trial summary

Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC 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-small Cell Lung Cancer
What is being tested?
IBI308 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
2 sitesChina
Study dates
1 Sep 2017to 22 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects with Histologically or cytologically confirmed squamous cell NSCLC
  • Subjects with stage IIIB/stage IV or recurrent disease (not suitable for definitive concurrent chemoradiotherapy) (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) after failure of first-line platinum-based therapy; Subjects who developed recurrent disease <6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy also could also be eligible.
  • At lease one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Age ≥ 18 and ≤ 75
  • ECOG performance status 0-1
  • Life expectancy of at least 12 weeks
Show all 12Show fewer
  • Adequate organ and bone marrow function
  • CBC: absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelet count (PLT) ≥ 100 × 109 / L; hemoglobin content (HGB) ≥ 9.0 g / dL.
  • Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum albumin ≥ 28 g / L.
  • Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 40 mL / min (calculated using Cockcroft / Gault equation) Female:CrCl= (140-Age) x Weight(kg) x 0.85 72 x Serum creatinine (mg/dL) Male:CrCl= (140-Age) x Weight(kg) x 1.00 72 x Serum creatinine (mg/dL)
  • Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study treatment.
  • Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study

Who cannot join

  • EGFR mutation and ALK rearrangement
  • Mixed adeno-squamous carcinoma or other pathological type
  • Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody or docetaxel
  • Have received following treatment:
  • Received any investigational agent within 4 weeks of the first dose of study treatment.
  • Received any anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study treatment.
Show all 33Show fewer
  • Received radiotherapy within 4 weeks of the first dose of study treatment.
  • Received systemic treatment with high-dose corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive drugs within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
  • Received attenuated live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Received major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study drugs or open wound, ulcer or fracture.
  • Unrecovered toxicity (grade >1, according to NCI CTCAE 4.03) due to prior anti-tumor therapy before the first dose of study treatment.
  • Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
  • Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other components used in their preparation.
  • Hemoptysis within 4 weeks of randomization (≥ 1/2 spoon per time).
  • Received thoracic radiotherapy >30Gy within 6 months or palliative radiotherapy (brain or bone metastasis) ≤30Gy within 7 days of randomization.
  • Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects should have stable disease more than 4 weeks from first dose of study treatment, with neurological symptoms returned to NCI CTCAE 4.03 grade 0 or 1, are permitted to enroll.
  • Subjects with a history of interstitial lung disease
  • Superior vena caval obstruction syndrome;
  • Uncontrolled third space effusion, eg. ascites or pleural effusion.
  • Uncontrolled concomitant disease, including but not limited to :
  • Active or poorly controlled severe infection
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
  • Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection
  • Active tuberculosis
  • Symptomatic congestive heart failure (New York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia
  • Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg)
  • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment
  • Concomitant disease needs anticoagulant therapy
  • Uncontrolled hypercalcemia(Ca2+>1.5mmol/L or Ca >12mg/dl or corrected Serum Calcium >ULN),or Symptomatic hypercalcemia during diphosphonate therapy
  • Other primary malignancy, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma;)
  • Subjects with other diseases or abnormal Lab test results which might increase the risk of enrollment and treatment or Interfere with the interpretation of study results could be excluded according to the judgments of investigator.
  • Women who are pregnant or nursing

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital Zhejiang University

    Hangzhou, Zhejiang

  • Jiangsu Cancer Hospital

    Nanjing

Other trials in China

About this study

Official title: Efficacy and Safety Evaluation of IBI308 Versus Docetaxel in Patients With Advanced or Metastatic Squamous Cell Lung Cancer After Failure of First-line Platinum-based Therapy- a Randomized, Open-label, Multicenter, Parallel, Phase 3 Study (ORIENT-3)

Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

Additionally, the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC patients as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

Being tested
IBI308, Docetaxel
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.

  • IBI308Drug

    Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

  • DocetaxelDrug

    As 2nd line treatment to subjects with squamous NSCLC

Study groups in NCT03150875
Study groupRoleWhat they receive
IBI308Experimentalinjection; dosage form: 10ml:100mg; frequency: 200mgQ3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria
Receives: Drug: IBI308
docetaxelActive comparatorinjection; dosage form: 1ml:40mg; Frequency: 75mg/m2 Q3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall Survival

    Overall survival was defined as the time from randomization to death due to any cause.

    Measured: Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Secondary outcomes (4)

  1. Progression-free Survival by Investigators' Assessment

    Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by investigators per RECIST 1.1 was reported for each arm.

    Measured: Through database cutoff date of 31-July-2020 (up to approximately 35 months)

  2. Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators

    ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

    Measured: Through database cutoff date of 31-July-2020 (up to approximately 35 months)

  3. Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators

    For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented.

    Measured: Through database cutoff date of 31-July-2020 (up to approximately 35 months)

  4. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

    TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated.

    Measured: Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Timeline

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

  1. First posted12 May 2017
  2. Study start1 Sep 2017
  3. Primary completion22 Feb 2023
  4. Study completion22 Feb 2023

Resources

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
None (open label)
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150875
Sponsor's protocol ID
CIBI308C301
Status last verified
Feb 2023
First submitted
7 May 2017
Last updated
28 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi Y, Wu L, Yu X, Xing P, Wang Y, Zhou J, Wang A, Shi J, Hu Y, Wang Z, An G, Fang Y, Sun S, Zhou C, Wang C, Ye F, Li X, Wang J, Wang M, Liu Y, Zhao Y, Yuan Y, Feng J, Chen Z, Shi J, Sun T, Wu G, Shu Y, Guo Q, Zhang Y, Song Y, Zhang S, Chen Y, Li W, Niu H, Hu W, Wang L, Huang J, Zhang Y, Cheng Y, Wu Z, Peng B, Sun J, Mancao C, Wang Y, Sun L. Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3). Cancer Commun (Lond). 2022 Dec;42(12):1314-1330. doi: 10.1002/cac2.12385. Epub 2022 Nov 6.

    PubMed 36336841

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI308 and Docetaxel in people with Non-small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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 12 inclusion and 33 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 28 Feb 2023. 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. 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?

Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Through database cutoff date of 31-July-2020 (up to approximately 35 months)). 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 NCT03150875, 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 28 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in