18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)Primary· Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the s
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
51.6
46.38 – 56.89
Avastin / Paclitaxel / Carboplatin
53.7
48.43 – 58.87
ORR at Week 19Secondary· From the date of randomization up to Week 19.
ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
47.8
42.57 – 53.07
Avastin / Paclitaxel / Carboplatin
51.0
45.71 – 56.18
Progression-free Survival (PFS)Secondary· Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicate
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
7.72
7.46 – 7.98
Avastin / Paclitaxel / Carboplatin
7.62
6.90 – 7.82
Overall Survival (OS)Secondary· Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
14.13
12.52 – 16.56
Avastin / Paclitaxel / Carboplatin
16.95
14.65 – 19.02
Duration Of Response (DOR)Secondary· Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
6.47
5.39 – 7.69
Avastin / Paclitaxel / Carboplatin
6.31
4.93 – 7.29
Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NEDSecondary· Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
87.6
83.81 – 90.84
Avastin / Paclitaxel / Carboplatin
87.5
83.64 – 90.68
Serum Trough Concentration (Ctrough)Secondary· Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.
Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome m
Cycle 1, Day 1 end of infusion
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
255.15
± 184.3
Avastin / Paclitaxel / Carboplatin
245.11
± 206.8
Cycle 2, Day 1 pre-infusion
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
42.74
± 91.9
Avastin / Paclitaxel / Carboplatin
48.48
± 77.3
Cycle 4, Day 1 pre-infusion
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
77.16
± 69.4
Avastin / Paclitaxel / Carboplatin
83.26
± 85.5
Cycle 4, Day 1 end of infusion
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
339.91
± 91.3
Avastin / Paclitaxel / Carboplatin
373.92
± 51.6
Cycle 6, Day 1 pre-infusion
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
87.25
± 124.5
Avastin / Paclitaxel / Carboplatin
108.22
± 69.8
Proportion of Patients Developing Anti-drug Antibodies (ADAs)Secondary· Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.
The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.
ADA prevalence (ADA positive, baseline or post)
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
3.0
Avastin / Paclitaxel / Carboplatin
3.0
Treatment-emergent ADA positive (ADA incidence)
Group
Value
95% CI
FKB238 / Paclitaxel / Carboplatin
2.3
Avastin / Paclitaxel / Carboplatin
2.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centus Biotherapeutics Limited
Last refreshed: 10 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02810457.